Quality Assurance Manager - Life Sciences R&D

Quality Assurance Manager

Skill required: Quality Governance & Operations - Operational Audit & Compliance
Designation: Quality Assurance Manager
Qualifications:Bachelor of Pharmacy/Master of Pharmacy
Years of Experience:13 to 18 years
About Accenture
Accenture is a global professional services company with leading capabilities in digital, cloud and security.Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song— all powered by the world’s largest network of Advanced Technology and Intelligent Operations centers. Our 784,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. We embrace the power of change to create value and shared success for our clients, people, shareholders, partners and communities.Visit us at www.accenture.com
What would you do? You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the world’s leading biopharma companies bring their vision to life – enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience. Quality Governance & Operations involves establishing and maintaining standards and processes to ensure the quality of products or services. This includes setting quality policies, conducting audits, and monitoring compliance with regulations. The goal is to create a consistent and reliable framework for quality management. Effective quality governance helps in minimizing risks, improving performance, and ensuring customer satisfaction. It is essential for maintaining the integrity and reputation of an organization. Audit and manage effective implementation and delivery of functional processes within operations to mitigate risk. e.g. Policies; Anticorruption, BCM, InfoSec, P104, Records Management and Contractor controls. Establish processes to audit/validate current control effectiveness and drive improvements wherever required.
What are we looking for? •Creation and implementation of Portfolio Quality Management framework for the assigned LS R&D engagement. • Establish quality and compliance activities for existing and new scope of services. • Lead and act as the point of contact for client audits and inspections by regulatory authorities. • Lead/contribute to the creation of formal processes; review and approve them as applicable. • Assume overall document management responsibility for the assigned project. • Ensure data security and privacy measures are implemented across deal teams, delivery leads, and representatives. • Lead Quality Governance meetings with clients, share compliance metrics, assign action items, and track them to closure. • Ensure deviations and CAPAs are managed effectively and closed on time. • Monitor and contribute to contract updates and ensure process changes are implemented and tracked. • Drive standardization of processes and systems across project locations. • Lead execution of audit/inspection recommendations and maintain evidence of completion. • Develop and execute deliverables in the Quality Management Plan in line with contract requirements.
Roles and Responsibilities: •In this role you are required to identify and assess complex problems for area of responsibility • The person would create solutions in situations in which analysis requires an in-depth evaluation of variable factors • Requires adherence to strategic direction set by senior management when establishing near-term goals • Interaction of the individual is with senior management at a client and/or within Accenture, involving matters that may require acceptance of an alternate approach • Some latitude in decision-making in involved • you will act independently to determine methods and procedures on new assignments • Decisions individual at this role makes have a major day to day impact on area of responsibility • The person manages large - medium sized teams and/or work efforts (if in an individual contributor role) at a client or within Accenture • Please note that this role may require you to work in rotational shifts