Quality Assurance - GMP&Clinical (d / f / m)

Depending on the candidate`s seniority, the incumbent will provide Quality Assurance oversight for Phase 3 clinical development, ensuring GMP and GCP compliance for clinical trial material and trial execution (small molecules drugs).

• Lead / Support establishment and maintenance of the Quality Management System appropriate for Phase 3
• Own / Contribute to GMP oversight of drug substance, drug product, packaging, labeling, and testing activities
• Manage / Coordinate batch record review, lot disposition, and clinical supply release
• Lead / Support deviation, CAPA, and change control activities impacting Phase 3 material
• Oversee / Participate in vendor and CDMO quality oversight and audits
• Ensure / Support inspection readiness for GMP and GCP inspections
• Lead / Support Quality input to stability programs and expiry management
• Approve / Review quality documentation depending on delegated authority

In order to be considered for the role, the selected candidate must have :

Relevant experience in QA phase 3 (small molecules) :

The selected candidate will be part of a dynamic team in an international environment and actively contribute to shape, develop, and drive the market authorization of innovative drugs. Hybrid work model (3 days onsite). Extension or take-over possibility.