IT Quality Specialist Clinical Submissions Management - Pharma R&D

IT Quality Specialist Clinical Submissions Management - Pharma R&D

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Job description

As an IT Quality Specialist at the SE6 level, you independently manage end-to-end software quality assurance and analysis tasks across various capabilities and contribute to solving moderately complex SDLC and release problems. You will lead the analysis of stakeholder needs, drive root cause analysis, and ensure comprehensive requirements traceability across large-scale initiatives. Acting as a trusted advisor, you will champion accountability, mentor junior team members, and drive process improvements that align delivered solutions with overarching business goals.

Description of the area

Job Responsibilities

• Scope / (Content Leadership): Independently manages end-to-end software quality tasks across various capabilities and contributes to more complex problems. Mentors more junior team members and contributes to the development of Quality Specialist best practices.

• Accountability/Problem Solving: Independently leads the analysis of moderately complex business problems, clearly defining the problem scope and driving root cause analysis. Elicits, analyzes, and synthesizes complex stakeholder needs, ensuring comprehensive requirements traceability across large-scale initiatives. Assures the delivery of comprehensive and well-structured requirements, contributing significantly to the design and validation of effective solutions. Analyzes technology fit, proposes effective solutions, and proactively identifies discrepancies and improvement opportunities.

• Stakeholder Management: Identifies a diverse range of stakeholders across functional areas, analyzing their influence and impact on project outcomes. Interacts within and across multiple product squads within a domain, facilitating workshops and resolving conflicts to ensure alignment. Proactively shapes stakeholder perspectives, anticipates and strategically manages expectations in complex projects, and builds reliance through deep business understanding to act as a trusted advisor.

• Impact/Strategy: Demonstrates strong and consistent performance across diverse products, with impact typically extending to a specific product, initiative, or cluster. Contributes to the achievement of a product initiative and potentially domain goals by ensuring that delivered solutions meet business needs and provide demonstrable value. Takes a proactive role in shaping team processes, contributes to Communities of Practice (CoPs), and translates requirements into strategic implementation plans that align with overall business objectives.

• Complexity/ (Product Size): Manages quality activities on more complex projects or across multiple products within a domain. Handles ambiguous requirements and evaluates solution impacts considering both immediate and longer-term implications within the domain. Ensures alignment with broader goals, manages interdependencies between related processes, and navigates intricate stakeholder environments.

• Business/Technical ability: Demonstrates a strong understanding of the business domain, related technologies, and their interdependencies. Can independently apply tools, principles, concepts, and techniques related to requirements, data, usability, and process analysis. Effectively handles interdependencies, managing the interconnections between various processes to improve overall efficiency and effectiveness.

Qualifications

Education / Experience

• Bachelor's degree in Computer Science, Software Engineering, or related technical field. Having professional certifications is an advantage.

• 5 to 8 Years of experience in independently managing end-to-end analysis tasks across various capabilities and driving root cause analysis for moderately complex problems.

• Proven track record of building reliance through deep business understanding, acting as a trusted advisor, and managing diverse cross-functional stakeholders.

• Establish and maintain QA standards and best practices, define testing scope and testing strategies for projects, review project requirements to identify potential quality issues early, develop quality metrics and KPIs for monitoring, ensure compliance with regulatory requirements and industry standards.

Technical Skills

• Strong capability to independently apply tools, principles, concepts, and techniques related to requirements, data, usability, and process analysis.

• Ability to evaluate solution impacts (both immediate and long-term) and analyze technology fit for effective solutions.

• Advanced proficiency in tools like JIRA, ALM, Quality Systems, Test automation frameworks, API testing, etc.

• Follow SDLC and Agile methodologies (Scrum, Kanban, etc.), participate in requirements reviews and design discussions, document testing procedures and maintain test documentation, conduct peer reviews of test cases and test scripts, implement quality gates and exit criteria

• Generate test reports and quality dashboards, communicate testing status to development and project teams, present quality metrics to management and stakeholders, collaborate with developers on issue resolution, participate in release readiness reviews

Additional Qualifications

• Ability to champion accountability by example, drive process improvement initiatives, and mentor junior team members.

• Extensive experience in pharma or biotech computer system validation (CSV) that strictly complies with GxP frameworks (GCP/GMP/GVP).

• Identify opportunities to improve QA processes, research and evaluate new testing tools and technologies, mentor team members and provide QA guidance, stay updated on industry trends and best practices, and implement lessons learned from previous projects.

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Who we are

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.

Experience Level

Mid Level