Senior QA Operations Manager GMP/GDP

Senior QA Operations Manager GMP/GDP - Pharma | Basel Region

• Start: November 2026, early December at the latest
• Duration: 12 months
• On-site: Minimum 3 days per week, with the remaining time remote
• Provide QA oversight for drug substance and drug product activities at CMOs throughout the product lifecycle
• Lead the management of deviations, OOS results, complaints and investigations, including CAPA definition and follow-up
• Support the release of APIs, bulk products and investigational medicinal products, including batch record review and change control assessment
• Draft and manage GMP/GDP agreements with CMOs
• Represent QA topics within the CMC team
• Write and approve SOPs
• Review and monitor CMO quality KPIs
• Act as a key QA contact for external manufacturing partners and internal stakeholders
• Master's degree in Pharmacy, Chemistry or a related scientific discipline
• 3-6 years of experience in QA within drug substance and/or drug product
• Ideally, experience across QC, analytical or production activities in addition to QA
• Proven experience working with external contract manufacturers / CMOs
• Strong knowledge of cGMP and GDP requirements
• Independent, assertive and comfortable working in a fast-paced project environment
• German or French would be an advantage