Quality Excellence Lead

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

At Roche, our commitment to quality in Pharma Development is unwavering. We deliver confidence in the integrity of our data, agility in our processes, and transparency with regulators, patients, and society.

As Quality Excellence Lead in our Quality Excellence Infrastructure team, you will help shape and elevate our global quality ecosystem, optimizing systems, streamlining processes, and providing expert advice. This role requires robust knowledge of Deviation and CAPA management processes in the GCP/GVP domain.

Key Responsibilities

• Contributes to the development, implementation, maintenance, and improvement of infrastructure strategies to enable outcomes, efficiencies, and productivity gains.
• Maintains Quality data to fulfill regulatory requirements and develops key data insights to catalyze decision making.
• Manage process-related inquiries, providing expert guidance on workflow troubleshooting.
• Manage deviations, oversee CAPA planning and perform thorough impact assessments.
• Collate data and derive actionable insights, leveraging functional dashboards and KPIs to identify systemic risks and emerging compliance trends.
• Resolve complex queries and oversee metric escalation.
• Supports implementation and continuous improvement of innovative Quality tools and technologies.
• Contributes to the development of business methodology including the use of data analytics and maintains related tools/procedures.
• Supports large-scale changes with systems-thinking, strategic collaboration, and alignment across the business to streamline and accelerate quality outcomes.

Who You Are

You are a resilient, data-driven quality professional who excels at bringing clarity and structure to complex, fast-paced environments.

To be successful in this role, you bring

• Digital & Data Literacy: Proven proficiency in analyzing data to drive solutions using modern tools, including strong competency utilizing AI and AI agents
• Proven GCP and / or GVP Expertise: Hands-on experience in clinical development, clinical trial operations, or clinical quality assurance, with in-depth knowledge of GCP guidelines (ICH GCP) and / or GVP. Preferably strong technical knowledge in areas like MDR, SaMD, QMS, or Risk-Based Quality Management (RBQM).
• RCA & SMART CAPA Mastery: Strong track record in root cause investigation, impact assessments, and corrective/preventive action implementation for deviations.
• Regulatory & Audit Readiness: Experience participating in or facilitating GCP/GVP audits or health authority inspections within pharma, biotech, or clinical research organizations.
• Audit & Inspection Experience: A track record of participating in and facilitating regulatory audits and inspections.
• Stakeholder Partnership & Change Leadership: Drives cross-functional collaboration and alignment on quality initiatives through effective negotiation, influencing, change management, and resilient stakeholder engagement
• Problem-Solving & Collaboration: Outstanding critical thinking, decision-making, and communication skills, with a passion for coaching and upskilling colleagues and developing future talent.
• Independent & Collaborative Delivery: Demonstrated ability to work self-sufficiently to achieve results, while thriving as a reliable, adaptable partner within broader global teams.

Please kindly provide a cover letter alongside your CV.

The interview process will consist of a screening video interview, followed by a case study presentation as part of the interview process.

Relocation benefits are not available for this job posting.

Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Welwyn. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.

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.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.