Riporting manager állások Svájcban (minőségbiztosítás)

QA MANAGER - DRUG PRODUCT CLINICAL MANUFACTURING (M/F/D) - QUALITY ASSURANCE / PHARMACEUTICAL / CGMP / SYNTHETIC MOLECULES / GMP AUDITS / SAP / VEEVA / GERMAN / ENGLISH PROJECT: For our client, a large pharmaceutical company based in Basel, we are looking for a QA Manager (m/f/d) Drug Product...

The role combines two aspects: the Technical Support to Regions (TSR-API), which entails addressing any Regulatory Affairs and Quality Assurance needs that arise in the assigned region (EMEA), and the Technical Support to Manufacturers (TSM-API), which involves acting as the central point of...

• Lead and coordinate CMC development activities for innovative small molecule anti-infective drug candidates
• Drive late-stage CMC readiness for key clinical and regulatory milestones, including Phase 3 preparation

• Lead and develop the Product Risk Management team
• Own and continuously improve the risk management process according to ISOwithin our product development framework
• Ensure high-quality risk analyses and maintain consistent, audit-ready risk management documentation

• Serve as the primary regulatory contact for Swissmedic for assigned products
• Prepare and manage regulatory submissions for new marketing authorisations and lifecycle changes
• Develop and implement regulatory strategies for Switzerland in coordination with international teams