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Rupa Industries

Quality Assurance And Quality Control Executive

Liberty

Job Description Summary:
We are seeking a dynamic and technically proficient Professional to drive strategic client engagement and technical advocacy within our construction chemicals division. This role is pivotal in building and nurturing relationships with key stakeholders including architects, consultants, developers, and government officials, ensuring our products are specified and adopted across high-impact projects. The ideal candidate will act as a technical liaison, promoting product awareness through targeted seminars, training sessions, and site-level support, while contributing to business growth by aligning technical solutions with project requirements. Your expertise will directly influence sales performance, market penetration, and long-term client partnerships across Hyderabad and Bangalore.

Responsibilities:
Develop and manage a robust network of key clients, including architects, consultants, developers, and government officials, to drive product specification and support sales targets.
Lead and conduct technical seminars and presentations at client offices to enhance product awareness and establish technical credibility.
Deliver comprehensive training sessions for the regional sales team and contractors on product applications, technical standards, and best practices.
Monitor and support site execution activities by visiting project sites and collaborating with clients, PMCs, architects, consultants, and contractors to ensure correct product application and timely resolution of technical issues.
Prepare and deliver specification drawings, mix designs, and technical documentation tailored to project-specific client requirements.
Compile and submit detailed monthly and quarterly performance reports to senior management, highlighting progress, challenges, and strategic insights.
Plan and spearhead major architectural presentations across the northern region to promote brand visibility and secure new business partnerships.


Requirements Requirements:

Bachelor’s degree in Civil Engineering or a related field; postgraduate qualification is a plus.
Minimum of 5 years of experience in technical sales, product management, or field application engineering within the construction chemicals or building materials industry.
Proven track record in building relationships with architects, consultants, and developers, with a strong understanding of specification processes.
Excellent presentation, communication, and training skills with the ability to translate technical information for diverse audiences.
Strong project coordination and reporting abilities, with proficiency in preparing technical documents and reports.
Willingness to travel frequently across Hyderabad and Bangalore, including site visits and client meetings.
Proficiency in MS Office and technical drawing tools (AutoCAD or similar) is preferred.




2Coms Consulting Pvt Ltd.

Specification Manager

Quality & Performance Senior SpecialistReq ID: 344179 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.We are currently seeking a Quality &amp; Performance Senior Specialist to join our team in Hyderabad, Telangana (IN-TG), India (IN).Manual and TestComplete Automation TesterManual and TestComplete Automation TesterA Manual and TestComplete Automation Tester who is responsible for ensuring software quality through both manual and automated testing methods. Design and execute manual test cases, develop and maintain automated test scripts using TestComplete, identify and report defects, and collaborate with other team members to ensure product quality.  Key Responsibilities: Manual Testing: Design and execute manual test cases based on functional requirements, identify defects, and track them to resolution. TestComplete Automation: Develop, maintain, and execute automated test scripts using TestComplete automation testing tool. Documentation: Create and maintain test documentation, reports, and test plans. Collaboration: Collaborate with developers, product managers, and other team members to understand product requirements and ensure quality. Defect Management: Identify, log, and track software defects, ensuring they are resolved efficiently. Regression Testing: Conduct regression testing to ensure application stability after changes. Compliance: Ensure compliance with testing standards and best practices.  Skills and Qualifications: Testing Experience: Experience in manual and automated testing, with a good understanding of testing methodologies and best practices. TestComplete Proficiency: Strong knowledge and experience with TestComplete, including scripting and automation techniques. Software Development Knowledge: Understanding of software development lifecycles, testing stages, and relevant software testing tools. Problem-Solving: Ability to identify, analyze, and resolve software defects. Communication: Good communication and collaboration skills to work effectively with various team members. Analytical Skills: Ability to analyze test results, identify trends, and make recommendations for improvement.  Tools and Technologies: TestCompleteBug Tracking Systems: ADO Scripting Languages: (VBScript, JavaScript, C# Script, depending on TestComplete configuration)About NTT DATANTT DATA is a $30 billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long term success. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure and connectivity. We are one of the leading providers of digital and AI infrastructure in the world. NTT DATA is a part of NTT Group, which invests over $3.6 billion each year in R&amp;D to help organizations and society move confidently and sustainably into the digital future. Visit us at <a href="http://us.nttdata.com/en">us.nttdata.com</a>Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, <a href="https://us.nttdata.com/en/contact-us">https://us.nttdata.com/en/contact-us</a>.NTT DATA endeavors to make <a href="https://us.nttdata.com">https://us.nttdata.com</a> accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at <a href="https://us.nttdata.com/en/contact-us">https://us.nttdata.com/en/contact-us</a>. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click <a href="http://us.nttdata.com/en/compliance#eeos">here</a>. If you'd like more information on your EEO rights under the law, please click <a href="http://us.nttdata.com/en/compliance#know-your-rights">here</a>. For Pay Transparency information, please click<a href="http://us.nttdata.com/en/compliance#ppnp"> here</a>.<h4>Experience Level</h4>Senior Level

NTT DATA Global Delivery Services Ltd

Quality Specialist

Principal Quality EngineerAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.About the Technology Organization Technology at Lilly builds and maintains capabilities using pioneering technologies like most prominent tech companies. What differentiates Technology at Lilly is that we create new possibilities through tech to advance our purpose – creating medicines that make life better for people around the world, like data driven drug discovery and connected clinical trials. We hire the best technology professionals from a variety of backgrounds, so they can bring an assortment of knowledge, skills, and diverse thinking to deliver solutions in every area of our business. About the Business Function The Software Product Engineering (SPE) team is a specialised engineering group that delivers strategic solutions and differentiated capabilities. We take a forward-thinking approach, focusing on an enterprise platform and product mindset, ensuring that the solutions we build can be leveraged across Technology teams for broader impact and efficiency. Within SPE, the Quality Engineering function ensures that every product meets the highest standards of performance, security, compliance, resilience, and user experience. Job Title: Principal Quality Engineer/Test Architect   Role Summary As a Principal Quality Engineer and Test Architect, you will define and drive the overall test architecture strategy across enterprise platforms, microservices, and cloud‑native applications. You will design scalable, maintainable, and future‑ready quality engineering frameworks, ensuring that testing is embedded into every stage of the software development lifecycle. You will partner with engineering leadership, product owners, and DevOps teams to establish best‑in‑class practices for automation, performance, security, accessibility, and resilience testing — while mentoring and guiding quality engineers across multiple teams.   What You’ll Be Doing <ul><li>Architect enterprise‑level test automation frameworks for backend services, APIs (REST) and frontend applications using Webdriver.IO, Jest, React Testing Library, Cypress, Playwright, and emerging tools. </li></ul><ul><li>Define and enforce quality engineering standards, coding guidelines, and architectural patterns for test automation across multiple product lines. </li></ul><ul><li>Lead contract testing strategy (e.g., Pact) to ensure API compatibility across microservices and external integrations. </li></ul><ul><li>Design performance, scalability, and resilience testing frameworks for distributed systems, event‑driven architectures, and serverless workloads. </li></ul><ul><li>Integrate security testing (SAST, DAST, dependency scanning) into CI/CD pipelines, ensuring compliance with healthcare regulations (HIPAA, GDPR). </li></ul><ul><li>Establish observability validation practices — ensuring logs, metrics, and traces meet operational and troubleshooting needs. </li></ul><ul><li>Drive chaos engineering initiatives (AWS Fault Injection Simulator, Gremlin) to validate fault tolerance and disaster recovery strategies. </li></ul><ul><li>Oversee accessibility testing aligned with WCAG 2.1/2.2 standards, ARIA roles, and automated audits (axe‑core). </li></ul><ul><li>Collaborate with DevOps to embed continuous testing into CI/CD pipelines using GitHub Actions, Docker, and AWS deployment workflows. </li></ul><ul><li>Evaluate and introduce AI‑assisted testing tools for intelligent test generation, defect prediction, and risk‑based testing. </li></ul><ul><li>Mentor and coach quality engineers, fostering a culture of technical excellence and continuous improvement. </li></ul><ul><li>Advise product and engineering leadership on quality metrics, risk assessment, and release readiness. </li></ul><ul><li>Champion shift‑left testing and test‑driven development (TDD/BDD) across teams. </li></ul>  How You Will Succeed <ul><li>Proven ability to design and implement enterprise‑scale test architectures. </li></ul><ul><li>Deep understanding of microservices, cloud infrastructure, and distributed systems. </li></ul><ul><li>Expertise in performance, security, resilience, and compliance testing in regulated environments. </li></ul><ul><li>Strong leadership and mentoring skills, with the ability to influence cross‑functional teams. </li></ul><ul><li>Strategic thinking with a focus on scalability, maintainability, and future‑proofing. </li></ul><ul><li>Excellent communication skills for technical and executive audiences. </li></ul>  What You Should Bring <ul><li>10+ years of professional experience in software quality engineering, with at least 3 years in a test architect or principal role. </li></ul><ul><li>Experience influencing enterprise‑wide quality strategies. </li></ul><ul><li>Mastery of automated testing tools (Webdriver.IO, Jest, React Testing Library, Cypress, Playwright) and frameworks for backend and frontend. </li></ul><ul><li>Strong experience with backend services built on Node.js, Express.js, and PostgreSQL (Sequelize, Knex.js). </li></ul><ul><li>Expertise in Core Web Vitals and app performance optimisation using Jmeter/Loadrunner/any other equivalent tool. </li></ul><ul><li>Hands on experience in application evaluation AI tools like DeepEval, RAGAS.  </li></ul><ul><li>Expertise in cloud infrastructure testing (AWS preferred) and containerisation (Docker, Kubernetes). </li></ul><ul><li>Bachelor’s or Master’s degree in Computer Science, Computer Engineering, or related field. </li></ul><ul><li>Advanced knowledge of accessibility testing and WCAG standards. </li></ul><ul><li>Experience with REST API testing and contract testing. </li></ul><ul><li>Track record of leading quality engineering in regulated industries (Life Sciences a plus). </li><li>Experience with responsive design testing and cross‑browser compatibility validation. </li></ul><ul><li>Contributions to open‑source testing frameworks or QA communities. </li></ul>  Preferred Qualifications <ul><li>Experience with FeathersJS or similar service‑layer frameworks. </li></ul><ul><li>Knowledge of design system validation (Material‑UI, Ant Design). </li></ul><ul><li>Exposure to Veeva QMS systems and its Quality processes.</li></ul><ul><li>Familiarity with modern build tools (Webpack, Vite, Babel, ESLint) for test integration and static analysis. </li></ul><ul><li>Advanced experience with chaos engineering and resilience validation. </li></ul><ul><li>Deep familiarity with observability platforms (Grafana, Prometheus, OpenTelemetry). </li></ul>Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (<a href="https://careers.lilly.com/us/en/workplace-accommodation" rel="noopener noreferrer" target="_blank">https://careers.lilly.com/us/en/workplace-accommodation</a>) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLilly<h4>Experience Level</h4>Senior Level

Eli Lilly and Company India Pvt Ltd

Senior Quality Engineer

Design Quality Engineer IIAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.<h4>A Day in the Life</h4>Design Quality engineer to support tool package role for CST-ET projectsResponsibilities may include the following and other duties may be assigned<ul><li>Review new and modified product design documentation for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.</li><li>Ensure that product development projects and changes to existing products are conducted in compliance with FDA Quality System Regulations.</li><li>Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting,, and feasible product requirements that support the market needs</li><li>Complaint Handling Experience for the medical devices products</li><li>Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).</li><li>Partner with Software Engineering to assess risk, develop software design plans and documentation, ensure code and integration reviews occur, and to demonstrate software capability and maturity.</li><li>Strong in software design and development, software verification and validation activities</li><li>Oversee testing and analysis for standards and product requirements compliance.</li><li>Provide guidance and direction for sample size and statistical analysis of verification and validation test results.</li><li>Ensure successful transfer of new products to production facility by assisting in the development of process validation requirements (PFMEA, IQ, OQ, PQ) using appropriate statistical tools and techniques.</li><li>Review Design History Files and Technical Files for conformance to applicable requirements</li><li>Ensures applicability to SOUP / OTS validations in the product development</li><li>Participate when appropriate in audits</li><li>Participate and provide input to training on department / division procedures and policies</li><li>Participate when appropriate in internal and supplier audits.</li><li>Applies quality system regulations, applicable standards and guidance to multiple projects</li><li>Applies quality system regulations, applicable standards and guidance to multiple projects</li><li>Develops templates and training based on the quality system regulations, applicable standards and guidance.</li><li>Independently reviews all SW deliverables to ensure compliance with development process and the standard.</li><li>Delivers presentations to the QA organization on status and issues of assigned projects. Delivers training to departments outside of QA.</li></ul>Required Knowledge and Experience<ul><li>B E or B.Tech</li><li>Minimum 4-6 years of quality engineering experience or equivalence and overall 6-8 years of experience</li><li>Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485, and the Medical Device Directive.</li><li>Good verbal and written communication skills including protocol / report development and technical presentations.</li><li>Familiar with ISO 9001, ISO 13485, IEC 62304, ISO 14971, IEC 60601, 21 CFR part 820, 21 CFR part 11, EUMDR and product specific industry standards.</li><li>Root cause failure analysis.</li><li>Previous experience working in a cross-functional team environment.</li><li>Working knowledge of and auditing experience to the FDA Quality System Regulation, ISO 13485</li><li>Familiar with statistical software tools (Minitab, Stat Graphics, Statistical)</li><li>Familiar with DMAIC or DMADV(DFSS) methodologies</li></ul>Physical Job Requirements The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. <h4>Benefits &amp; Compensation</h4>Medtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.  We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).<h4>About Medtronic</h4>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.  We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&amp;D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.Learn more about our business, mission, and our commitment to diversity <a href="http://www.medtronic.com" rel="noopener noreferrer" target="_blank">here</a>   <h4>Experience Level</h4>Senior Level

India Medtronic Pvt. Ltd

Fabrication Quality Engineer

Sr. Associate, Quality Compliance<h4>Career Category</h4>Quality<h4>Job Description</h4>ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.ABOUT THE ROLERole Description:The senior associate will work within R&amp;D Quality’s Business Intelligence and Data Analytics (BIDA) team to help deliver actionable information and recommendations to key leaders and stakeholders by maintaining and expanding our data pipelines, tools, and reporting. This role contributes to ensuring Amgen’s pursuit of life-saving medication is done with the highest regard for quality and compliance to regulations. Roles &amp; Responsibilities:As an integral team member working globally with BIDA, other R&amp;D Quality team members, and R&amp;D Quality stakeholders to ensure quality across our trials and compliance with GxP regulations and other requirements:<ul><li>Extract and clean data from internal systems for regular and ad hoc reporting, including data pipeline creation and maintenance</li><li>Generate, validate, and deliver KPIs, quality metrics, and performance indicators used across the R&amp;D Quality landscape</li><li>Investigate and analyze metric trends, anomalies, and operational insights</li><li>Design, build, and maintain Tableau dashboards for operational monitoring, compliance reporting, and executive summaries</li><li>Develop and maintain Python scripts used for data processing, transformation, and report automation</li><li>Help create reusable components for common data analysis tasks and documentation.</li><li>Ensure version control and proper documentation of scripts and workflows.</li></ul>Basic Qualifications and Experience:<ul><li>Master’s degree and 7-10 years in Pharma and Biotechnology R&amp;D Quality OR</li><li>Bachelor’s degree and 10-15 years of years in Pharma and Biotechnology R&amp;D Quality.</li></ul>Functional Skills:Must-Have Skills:<ul><li>Exceptional attention to detail and accuracy in all deliverables.</li><li>Ability to work independently and proactively in a fast-paced environment.</li><li>Proficiency with Tableau or similar data visualization tools</li><li>Familiarity with Python or other object-oriented programming language</li><li>Familiarity with SQL and Databricks</li><li>Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams)</li><li>Effective communication, critical thinking and problem-solving</li><li>Experience in conducting data analyses and translating data sets into actionable insights</li></ul>Good-to-Have Skills:<ul><li>Familiarity with project management tools and methodologies</li><li>Knowledge of GCP, GLP and/or GPvP</li><li>Familiarity with Databricks and SQL</li><li>Experience working in a multinational environment with global teams.</li><li>Experience within Biotech/pharmaceutical Research</li><li>Independent and teamwork capabilities</li></ul>Soft Skills:<ul><li>Excellent verbal and written communication skills</li><li>High degree of professionalism and interpersonal skills</li><li>Strong problem-solving abilities and adaptability to changing priorities</li><li>Collaborative mindset and ability to build positive relationships across diverse teams</li><li>Resilience, discretion, and the ability to thrive under pressure</li></ul>.<h4>Experience Level</h4>Senior Level

Amgen Technology Private Limited

Quality Assurance Officer

Associate Quality Compliance<h4>Career Category</h4>Quality<h4>Job Description</h4>Role Name: Associate Quality ComplianceDepartment Name: R&amp;D QualityRole GCF: 3ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. ABOUT THE ROLERole Description:The Controlled Documentation Associate plays a critical role in supporting Amgen’s R&amp;D Quality Management System through the execution and maintenance of controlled document workflows. This role ensures that R&amp;D controlled documents, such as SOPs and work instructions, are developed, maintained, and retired in compliance with global standards and GCP regulations. The associate will collaborate across functions to facilitate document approval processes, conduct quality checks, and support inspection readiness activities.Roles &amp; Responsibilities:<ul><li>Execute and track workflows for creation, revision, and obsoletion of documents with the controlled document management system (CDOCS).</li><li>Perform controlled document impact analysis in support of business requests and initiatives.</li><li>Maintain document metadata in CDOCS.</li><li>Conduct quality checks, editing, and proofreading of documents for consistency and compliance.</li><li>Monitor document workflows, notify stakeholders of pending tasks, and follow up to ensure timely completion.</li><li>Support inspections and audits by retrieving and compiling requested documents.</li></ul>Basic Qualifications and Experience:<ul><li>Masters Degree in Sciences or related field with 2-6 years exp in Pharmaceutical/Biotechnology/Clinical research</li></ul>Functional Skills:Must-Have Skills:<ul><li>Strong attention to detail with proven ability to perform quality reviews.</li><li>Working knowledge of document control tools and best practices.</li><li>Excellent verbal and written communication skills.</li><li>Ability to manage document workflows and prioritize tasks.</li></ul>Good-to-Have Skills:<ul><li>Experience working in a multinational environment with global teams.</li><li>Experience using CDOCS or equivalent electronic document management system.</li></ul>Soft Skills:<ul><li>Strong problem-solving abilities and adaptability to changing priorities.</li><li>Strong attention to detail and accuracy.</li><li>Excellent organization and coordination skills.</li><li>Clear and concise communication abilities.</li><li>Team-oriented and proactive approach.</li></ul>EQUAL OPPORTUNITY STATEMENTAmgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation..<h4>Experience Level</h4>Mid Level

Business Excellence . Looking for Candidate with 5+ years of experience.. Experience in Process improvement, Making Policies, and standard operating procedures (SOPs). . Working Environment: 5 Days. Immediate availability is a strong advantage.. Location - Sohini Tech Park, 6, 7, 10th Floors, Nanakramguda Village, Gachibowli, Hyderabad, Telangana, 500032 Share your CV with the position mentioned.

Latinem Private Limited 

Business Development Specialist

Senior Manager, Quality Assurance SpecialistWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank">careers.bms.com/working-with-us</a>.Key Responsibilities<ul><li>Identify opportunities for process improvements by analyzing current workflows, systems, and procedures related to CAPA management.</li><li>Lead cross-functional teams to drive process improvement projects from inception to completion.</li><li>Manage the CAPA process, including the identification, investigation, and resolution of non-conformances.</li></ul><ul><li>Act as a CAPA lead investigator to conduct and manage root cause analysis, perform impact assessment of GCP deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches.</li><li>Act as a subject matter expert (SME) to support the business develop robust CAPAs with adequate effectiveness checks resulting from deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches.</li></ul><ul><li>Presents investigation findings to key stakeholders across Global Drug Development (GDD) and/or Global Quality (GQ) and works with the business to track CAPAs &amp; effectiveness checks (where relevant) to completion.</li><li>Provide training and support to staff on process improvement methodologies and CAPA management.</li><li>Monitor the effectiveness of implemented CAPAs and process improvements through data analysis and performance metrics.</li></ul><ul><li>Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, to drive continuous improvement, and to streamline processes</li></ul><ul><li>Stay current with industry best practices and regulatory requirements related to process improvement and CAPA management.</li><li>Develops CAPA metrics and trend analysis to identify areas of improvement and drive continuous improvement.</li></ul><ul><li>Prepare and present reports on process improvement activities and CAPA status to senior management.</li></ul><ul><li>Serve as the Infinity system superuser and provide training to users, as needed.</li><li>Maintains strong and productive working relationships with key stakeholders throughout BMS with the ability to think enterprise wide.</li><li>Fosters Teamwork and Inclusion: Practices inclusion and seeks different perspectives. Builds effective teams committed to organizational goals; fosters inclusion and collaboration among teams to address relevant issues.</li><li>Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality.</li><li>Recognize Global Implications and diversity: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one’s own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches.</li><li>Demonstrates Adaptability: Handles day-today work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; show resilience in the face of constraints, frustrations or adversity; demonstrates flexibility.</li><li>Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.</li><li>Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new of modified approaches; brings perspectives and approaches together combining them in creative ways. Other:</li></ul><ul></ul>Qualifications &amp; Experience <ul><li>B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience</li><li>Minimum 7+ years GxP CAPA Management in Quality, Clinical Development or Regulatory Compliance. </li><li>Advanced Finding Investigation and Root Cause Analysis (RCA) proficiency. </li></ul>Required Competencies: Knowledge, Skills, and Abilities <ul><li>In-depth knowledge of GCP guidelines (e.g. ICH, FDA regulations), principles of Quality Assurance, and proven experience within Clinical Trial Execution (e.g. prior experience as CRA or Clinical Trial Manager).</li><li>Demonstrated problem solving ability and quality mindset.</li><li>Good interpersonal, oral and written technical communication skills are essential.</li><li>Drives for results and success; conveys sense of urgency and drives issues to closure; persists despite any obstacles.</li><li>Ability to work in a highly matrixed and complex environment.</li><li>Demonstrates strong critical thinking skills and ability to make ethical, scientifically sound recommendations or decisions for issues consistent with company policy, regulatory references, and business strategy.</li><li>Experience in leading investigations utilizing formal Root Cause Analysis tools is preferred (or the ability to obtain formal RCA training).</li><li>Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.</li><li>Experience using data analytics (i.e. control charts, heat maps, histograms, box plots). Considers global influences, situations, and implications when making plans or decisions, solving problems developing strategies.</li><li>Fosters a culture in which people continually work to improve services, and work processes.</li><li>Maintains the confidentiality and security of information, data, documents, and records.</li><li>Escalates issues to appropriate people within department/organization.</li><li>Sense of diplomacy and discretion.</li><li>Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.</li></ul>If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" rel="noopener noreferrer" target="_blank">adastaffingsupport@bms.com</a>. Visit <a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">careers.bms.com/</a><a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">eeo</a><a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">-accessibility</a> to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: <a href="https://careers.bms.com/california-residents/" rel="noopener noreferrer" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.<h4>Experience Level</h4>Senior Level

Bristol-Myers Squibb India Pvt Ltd

Quality Assurance Specialist

Senior Quality Assurance EngineerJob Responsibilities:<ul><li>Design, implement, execute, and debug/fix automated tests of moderate complexity. </li><li>Identify risk and develop and implement mitigation plans under general supervision. </li><li>Configure regression framework to run against different instances. </li><li>Estimate effort required for given story or task. </li><li>Provide inputs and escalate issues in bug triage meetings and coordinate with development team. </li><li>Use developing skills to conduct root cause analysis, escalating significantly complex issues as necessary.  </li><li>Provide support and mentorship to team members. </li></ul> Minimum Qualifications: <ul><li>Bachelor’s Degree or equivalent in Computer Science or Engineering</li><li>2 Years of Relevant Experience</li></ul>Job Category Summary:Implements test automation and conducts a wide range of quality control tests, trials and analyses across systems and applications to ensure that software meets or exceeds specified standards and end user requirements. Drafts, revises and approves test plans and scripts to ensure alignment with standards and software strategy.  At Clarivate, we are committed to providing equal employment opportunities for all  qualified persons with respect to hiring, compensation, promotion, training, and other terms, conditions, and privileges of employment. We comply with applicable laws and regulations governing non-discrimination in all locations.<h4>Experience Level</h4>Senior Level

Clarivate

Quality Assurance Engineer

Quality Assurance Architect<h4>Company Description</h4>insightsoftware is a growing, dynamic computer software company that helps businesses achieve greater levels of financial intelligence across their organization with our world-class financial reporting solutions. At Insightsoftware, you will learn and grow in a fast-paced, supportive environment that will take your career to the next level. We are looking for future Insighters who can demonstrate teamwork, results orientation, a growth mindset, disciplined execution, and a winning attitude to join our growing team!The Equity Management team is growing fast, retaining an agile startup mindset but delivering enterprise solutions to the top players in the financial domain. This is your chance to be part of a team that delivers high quality software that changes the way our customers do business while having fun at work.Learn more at <a href="http://insightsoftware.com/">insightsoftware.com</a><h4>Job Description</h4>As a Quality Assurance Architect, you will serve as both the hands-on technical expert and transformational thought leader for Product Quality assurance, reporting to the QA Manager and providing strategic guidance and mentorship to approximately 10 QA engineers across both manual and automation disciplines. This position focuses on technical leadership and process excellence rather than people management - you will have no direct reports but significant influence over quality standards, team culture, and strategic direction.You will be joining a team that needs transformation from task-oriented execution to strategic quality thinking. We are looking for someone who can see the forest, not just the trees - someone who questions 'why' not just 'what' and can elevate a team from following procedures to driving quality innovation. You'll be accountable for driving quality excellence across multiple scrum teams while also rolling up your sleeves to build, maintain, and execute testing of our Equity Management SaaS Application.You will lead by example, actively participating in hands-on work while simultaneously challenging existing processes and driving innovative approaches. You'll be responsible for planning, designing and building test artifacts, developing and executing tests for new features, enhancements, and fixes, while also transforming how the team thinks about quality's role in business success.You will be a great fit for this position if you combine deep technical expertise with visionary thinking - someone who can execute at the highest level while inspiring others to think beyond their individual tasks and see quality as a strategic business driver.ResponsibilitiesLeadership &amp; Strategic Vision:<ul><li>As the senior technical leader and transformational change agent, drive quality assurance initiatives and elevate technical excellence</li><li>Partner with QA Manager to design, implement, and drive continuous improvement in QA processes and methodologies</li><li>Transform team mindset from reactive testing to proactive quality advocacy and strategic business thinking</li><li>Challenge existing processes and drive innovative approaches to quality assurance that impact business outcomes</li><li>Lead by asking the right questions, not just providing answers - help the team understand 'why' behind their work</li><li>Mentor and develop QA engineers across manual and automation disciplines, fostering critical thinking and strategic quality perspective</li><li>Drive technical standards and best practices across the QA organization while building a culture of continuous improvement</li></ul>Hands-On Technical Execution:<ul><li>Define &amp; document test plans, test cases and execute tests for each assigned work item</li><li>Collaborate with cross functional teams to understand and identify appropriate testing criteria</li><li>Identify test conditions, both positive and negative, from User Stories, Product Backlog Items, and other requirements documents</li><li>Execute test cases, document results, update progress and track bugs</li><li>Implement and maintain Automated Test Infrastructure and Test Suites</li><li>Align automation with the speed of development. Make informed decisions on what, how, and when to automate vs manually test</li><li>Design and execute non-functional testing (e.g., performance, security and accessibility) by using standard testing techniques</li></ul>Collaboration &amp; Process Participation:<ul><li>Participate in daily stand-ups, sprint planning and retrospectives, and other meetings as needed</li><li>Operate in an agile development team and participate in the design, development, testing, and debugging of applications</li><li>Review work items to estimate and work alongside senior engineers to propose testing solutions</li></ul><h4>Qualifications</h4>Total experience<ul><li>Minimum 10+ years of hands-on commercial software testing experience, with at least 5 years focused on SaaS applications</li></ul>Leadership &amp; Experience:<ul><li>3+ years of experience providing technical leadership and mentorship to QA teams of 8+ engineers, including both manual and automation specialists</li><li>Demonstrated ability to transform team culture and elevate thinking beyond tactical execution to strategic quality ownership</li><li>Proven track record of driving organizational change and challenging status quo approaches to achieve measurable improvements</li><li>Experience connecting quality initiatives to business impact and articulating value to stakeholders</li><li>Bachelor's degree in Computer Science, or equivalent work experience (preferably in Product companies)</li></ul>Core Technical Skills:<ul><li>8+ years of experience with defining &amp; documenting manual functional and non-functional testing</li><li>Minimum 5+ years coding experience in C# and SQL (our core tech stack)</li><li>Minimum 5+ years of experience in writing solid test automation frameworks</li><li>8+ years of experience with testing REST APIs (Postman, Curl)</li><li>Experience with additional programming languages and automation frameworks is a plus</li><li>Proven track record in performance optimization of test infrastructure and automated testing frameworks</li><li>Experience with performance and load testing</li></ul>Technical Knowledge &amp; Methodologies:<ul><li>Solid foundation of QA methodologies, testing techniques and software development processes in an agile environment</li><li>Solid understanding of the Agile SDLC</li><li>Minimum 5+ years of experience using Selenium WebDriver (our current automation framework)</li></ul>Tools &amp; Systems:<ul><li>Experience using JIRA, XRAY, ALM or other test management tools</li><li>Experience using TFS, JIRA, GIT, Jenkins or other CI/CD tools</li></ul>Communication &amp; Transformation:<ul><li>Strong communication skills -- written and verbal -- with ability to influence and inspire strategic thinking</li><li>Proven influencing and mentoring skills with ability to drive cultural transformation through technical expertise and vision</li><li>Experience elevating team performance by helping individuals see beyond their immediate tasks to understand broader business impact</li><li>Strong collaboration skills -- experience working in a small-team environment while driving change</li></ul>Preferred Qualifications:<ul><li>Experience with cloud technologies (Azure/AWS) is a plus</li><li>Experience in US-based Equity Compensation or other financial domain is a differentiator</li></ul><h4>Additional Information</h4>All your information will be kept confidential according to EEO guidelines. ** At this time insightsoftware is not able to offer sponsorship to candidates who are not eligible to work in the country where the position is located. **<a href="https://insightsoftware.wistia.com/medias/vzk90oshuy">insightsoftware About Us: Hear From Our Team - InsightSoftware (wistia.com)</a>Background checks are required for employment with insightsoftware, where permitted by country, state/province.At insightsoftware, we are committed to equal employment opportunity regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, veteran status, or other class protected by applicable law. We are proud to be an equal opportunity workplace.<h4>Experience Level</h4>Senior Level

insightsoftware

Senior Quality Assurance Engineer

Senior Process and Compliance ManagerJob Description SummaryResponsible for ensuring operational excellence related to clinical trial activities within Translational Clinical Oncology (TCO). Track progress to key quality indicators (KQIs), Quality Plan and overall compliance to applicable processes and regulations. Lead and assist in the development and implementation of process improvement initiatives within the function; ensure changes are adequately communicated and managed. Work collaboratively with clinical QA (CQA) and appropriate line functions to ensure that TCO upholds high quality standards. Job Description Major accountabilities: <ul><li>Accurate and timely execution of process improvement and quality initiatives as measured by meeting key milestones effectively.</li><li>Successful implementation of process improvements as measured by sustainable changes and improved efficiency.</li><li>Increased compliance with relevant processes.</li><li>Establish business partnerships with all relevant TCO functional groups, CQA, training and other LFs as required.</li><li>Training programs implemented in a timely fashion, and tracked to ensure compliance and maintenance</li></ul><h4> Impact on the Organization: </h4><ul><li>Improved quality of outputs</li><li>Increased compliance with SOP, GCP and training</li><li>Decreased audit/inspection findings</li><li>Efficient use of resources through operational effectiveness</li></ul><h4>Additional Details</h4><ul><li>KQIs - Responsible to track, report and reinforce adherence to applicable performance measures. Support in recommending corrective actions based upon report outputs and root cause analysis; and support implementing training/communication as applicable to ensure remediation (preventative actions). Support Clinical Trial Quality Risk Management (CTQRM) review by evaluating studies to ensure adherence to CTQRM SOP and follow-up with respective study leads.</li><li>SOPs - provide input into new SOPs/WPs on behalf of TCO as applicable, may serve as subject matter expert. Contribute to identifying training opportunities and ensuring compliance with new SOPs and Working Practices. Track quality issues and ensure their documentation within the quality event management system and implementation of corrective actions. Support the implementation and tracking of compliance to the clinical trial processes.</li><li>Quality Plan - Ensure that actions required of TCO are appropriately tracked.  Support the conduct of self-assessments for TCO in conjunction with CQA. Proactively ensure procedural deficiencies within TCO are corrected and prevented. Liaise with BR TM and CS&amp;I and appropriate Development LFs to ensure quality outcomes.</li><li>Process Expertise – identify or support the identification of procedural gaps and their correction with process improvements where applicable. Represent TCO/BR in cross-functional initiatives aiming for continual process improvement and ensuring a compliance focused environment either by direct involvement or by ensuring appropriate TCO/BR representation. May serve as Managed Access Program Champion.</li><li>Training -Support training/communications to assure understanding of new processes or findings.  Assure remediation. Identify gaps and assign action where needed to promptly gain compliance. Assist with change management activities related to new processes or organizational changes. Support/organize timely Lessons Learned sessions.</li><li>Compliance – As applicable based on assignment, ensure Corrective Actions Preventative Actions (CAPA) commitments are adequate, submitted and completed in a timely manner. Initiate and document root cause investigations of critical issues. Support inspection preparation and inspection readiness.  Ensure the timely submission and completion of adequate Corrective Actions Preventative Actions (CAPA). Ensure audit and inspection outcomes requiring corrective action are managed.</li><li>Act as TCO Protocol Review Committee Manager, as assigned: run PRC Office independently (meetings and agenda planning, uploading of documents in review system), maintain the PRC SharePoint site, system owner of the TCO PRC submission tracker, providing training and access and working with IT on system updates; maintain revisions to the PRC charter.</li><li>Act as BR-DOC Manager, as assigned – manage end-to-end document QC function with BR Translational Medicine – BR Doc function. Provide vendor management, track submissions and provide guidance to TCO teams.</li><li>As assigned, participate as a reviewer on the TCO Protocol Review Committee or assist with quality checks of documents (protocols, ICFs, etc) as appropriate per TCO process.</li><li>Escalate issues to TCO management and CQA in a timely manner.</li></ul> Minimum Requirements: Work Experience: <ul><li>A minimum of 5 years of relevant pharmaceutical clinical development experience</li><li>Extensive knowledge of clinical development process, GCP and clinical quality management; including strong understanding of regulation and guidance for clinical studies</li><li>Proficiency/Fluency in English</li><li>Experience working in matrix environment and in global teams.</li><li>Excellent interpersonal, problem-solving, negotiation and conflict resolution skills</li><li>Excellent organizational skills, as well as predisposition to quality management and process improvement</li><li>Excellent communicator and presenter (oral and written).</li></ul> Education: <ul><li>Bachelor of Science (BS) or advanced degree in scientific discipline or equivalent education in life science/healthcare required</li></ul> Languages :<ul><li>English.</li></ul> Skills DesiredAnalysis, Databases, Decision Making Skills, Operations, Problem Solving Skills, Reporting, Team Management, Waterfall Model<h4>Experience Level</h4>Senior Level

Novartis India

Process Manager

Manager, Digital Quality and GovernanceWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank">careers.bms.com/working-with-us</a>.Functional and Technical<ul><li>QA review and approval of validation deliverables associated with various BMS enterprise systems, including but not limited to clinical study databases, electronic Case Report Forms (eCRFs), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, ERP systems including SAP and Oracle, Veeva-based systems such as Clinical Trial Management Systems (CTMS), electronic Trial Master File (eTMF), Regulatory Information Management (RIM), and Quality Management Systems (QMS), as well as various Veeva Vault-based configurations. </li><li>Ensure adequate and timely quality assurance / regulatory compliance support</li><li>Provide support during regulatory agency and third party inspections</li><li>Research new technologies, understand existing processes, and reference recognized standards and frameworks</li><li>Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education.</li><li>Identify opportunities for continuous improvement</li><li>Adherence to BMS Core Behaviors</li><li>Conduct risk &amp; impact assessment to determine the extent of validation and qualification and ensure right sized validation effort for programs</li><li>Demonstrate critical thinking around interpreting business and industry challenges and recommending best practices-based solutions to improve products, processes, systems</li><li>Implement organizational IT controls in accordance with applicable regulations and the ability to evaluate and understand the impact of new regulations and requirements</li><li>Review Periodic Review assignments completions for applications in a timely manner</li><li>Support responses to application CAPAs and Audits as they relate to health authority investigations and internal audits in a timely manner-in coordination with multiple stakeholder teams</li></ul>Qualifications &amp; Experience<ul><li>B.E./B.Tech. or equivalent in computer science, engineering, life science field</li><li>A minimum of 5+ years of experience in Quality Assurance, IT Compliance and computer systems validation (CSV) in the pharmaceutical industry</li><li>Candidate must have a strong understanding of 21 CFR Part 11, EU Annex 11, Data Integrity principles, GAMP and Agile methodologies.  Additionally, good understanding of Computer Software Assurance principles desired.</li><li>Understanding of quality risk-management concepts (ICH Q9) preferred</li><li>Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures</li><li>Previous experience as a computer system validation / quality assurance / quality control analyst for a life sciences company regulated by the FDA (or equivalent) preferred</li><li>Familiarity with the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes</li><li>Experience with driving validation strategies across across the end-to-end product lifecycle as well as experience with widely used IT Enterprise platforms (MES, SAP, Veeva, Service NOW etc.) </li><li>General knowledge of IT applications, IT infrastructure, architecture of computer systems including SaaS, IaaS as well as networks, operating systems, databases, and software tools</li><li>Candidate must have strong knowledge of IT testing practices and methodologies in the pharmaceutical GxP space-and good working knowledge of tools like ALM and Valgensis</li><li>Ability to make decisions that impact own work and other groups/teams and works with minimal supervision</li><li>Ability to support various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team</li><li>Demonstrates openness to learning and developing. Takes a responsibility for their own and team’s development and growth</li><li>Demonstrates an understanding of factors driving team performance and how they contribute to the team's overall success</li><li>Strong sense of ethics, diplomacy and discretion</li><li>Commitment to Quality</li><li>Fluent in English, with proven professional working proficiency in English for reading, writing and speaking. including the ability to deliver clear and articulate presentations</li></ul>If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" rel="noopener noreferrer" target="_blank">adastaffingsupport@bms.com</a>. Visit <a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">careers.bms.com/</a><a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">eeo</a><a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">-accessibility</a> to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: <a href="https://careers.bms.com/california-residents/" rel="noopener noreferrer" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.<h4>Experience Level</h4>Mid Level

Digital Marketing Head

Senior Manager, Quality Risk AnalystWorking with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: <a href="https://careers.bms.com/working-with-us" rel="noopener noreferrer" target="_blank">careers.bms.com/working-with-us</a>.Key Responsibilities<ul><li>Help to develop the Quality Narrative at a study and TA level, to document the end-to-end risk-based quality management for critical to quality (CtQ) data, processes and vendors demonstrating effective risk and issue management. This will involve collecting all the relevant inputs from the Risk Based Monitoring (RBM) framework Clinical Oversight and Risk Management (CORM) as well as R&amp;D Quality Clinical Quality Assurance on audits and inspections.</li><li>Work with Drug Development, particularly the CORM function, to embed Quality by Design principles and help identify study specific CtQ data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.</li><li>Provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun. This will involve partnering with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.</li><li>At the study level, conduct spot checks to ensure risk mitigation strategies are accurately translated into operational plans and verification of action plans are implemented for risk mitigation.</li><li>Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.</li><li>Partner with the study teams to ensure effective management of significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.</li><li>Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.</li><li>Provide R&amp;D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.</li><li>Capture GxP (GCP) Non-compliance events and conduct trend analysis documenting accordingly.</li><li>Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.</li><li>Ensure compliance with ICH (E6, E8, E9) and other relevant regulatory requirements.</li><li>Involved in External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.</li></ul>Other:<ul><li>Champion a culture of quality by delivering forward-looking support across the business (e.g., deviation, CAPA, and process improvement), and consultation through GCP quality and clinical risk management experience. </li><li>Provide analytical support to fellow team members in relation to quality metrics/trending to support critical business programs and assets.</li><li>Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level.</li><li>Serve as part of strategic team(s) within the group/discipline.</li><li>Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to peers and business partners.</li><li>Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.</li><li>Excellent written and verbal English communication skills.</li><li>Analytics and AI tool experience are a plus</li></ul> Qualifications &amp; ExperienceDegree/Certification/Licensure: <ul><li>B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience</li></ul>Experience – Responsibility and minimum number of years:  <ul><li>Minimum of 7 years of experience with clinical trials including risk-based monitoring, clinical trial, trial data analysis, identify risk assessment, and reporting.</li><li>At least 5 years of experience in the leading and supporting QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance, audit and inspection.</li><li>Experience with QMS and systems supporting is a plus.</li></ul>If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" rel="noopener noreferrer" target="_blank">adastaffingsupport@bms.com</a>. Visit <a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">careers.bms.com/</a><a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">eeo</a><a href="https://careers.bms.com/eeo-accessibility" rel="noopener noreferrer" target="_blank">-accessibility</a> to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: <a href="https://careers.bms.com/california-residents/" rel="noopener noreferrer" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.<h4>Experience Level</h4>Senior Level

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