Senior Quality Lead

Senior Quality Lead – Quality Assurance Process & Affiliate Team

As a Senior Quality Lead within our Quality Assurance Process and Affiliate team, you will design and deliver risk‑based Quality Assurance strategies, audits, and conclusions for post‑approval products, affiliates, and processes. You will act as a trusted partner to senior business stakeholders, guiding cross‑functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes.

• Design and implement QA strategies across GCP, GVP, and Medical Device areas using the CtQ framework.
• Determine audit requirements, develop data‑analytics‑driven audit methodologies, and independently manage the end‑to‑end audit process.
• Manage quality issues, track systematic findings for process improvement, and elevate significant risks to PDQ management.
• Evaluate quality positions to drive compliance action plans and communicate quality conclusions to stakeholders.
• Lead preparation for major regulatory inspections (FDA, EMA) and present quality strategies and conclusions.
• Contribute to long‑term strategic direction of PDQ, lead compliance projects, and mentor emerging Quality Leads.

• Strong background in drug development, clinical trials, and cross‑functional quality experience in GCP, GVP/PV, or Medical Devices/SaMD.
• Proven track record of leading major Health Authority inspections (FDA, EMA) and managing post‑inspection activities.
• Advanced problem‑solving skills with a proactive, risk‑based mindset and proficiency in data and visualization tools.
• Exceptional relationship management skills and ability to influence senior stakeholders.
• Experience managing global, multicultural projects and mentoring others.
• Bachelor’s degree in a scientific or quality‑related field (advanced degree preferred).

Basel, Switzerland (hybrid role with ongoing site presence required). International business travel may be required, typically about 10% of the time.

Roche is an Equal Opportunity Employer.