Beschreibung
We are looking for a Senior Manager (m/w/d) Quality Assurance GCP for our client in the pharma sector.- Start: 01.01.2023 (in February at the latest)
- Duration: 6 months (extension possible)
- Location: 2 days/week in Munich area, rest remotely
- Workload: 100%
- Job number: JN -
Tasks:
- Actively leading or contributing to the strategic direction for a risk-based assurance program
- Lead, plan and conduct audits in GCP/GVP areas
- Working with contract personnel or consultants to prepare, conduct and report outsourced audits
- Leading or participating in the investigation of critical quality issues and ensure timely reporting of issues to relevant authorities
- Oversight of significant CAPAs for clinical activities
- Support and continuous improvement of the QM system related to GCP/GVP
- Management of external GCP/GVP QA related service providers
- Primary contact partner for advice to GCP relevant departments for creation of SOPs
- Conduct of internal trainings related to GCP as required
- Background in biology, chemistry, medicine or related discipline
- Fluent in English
- Expert knowledge in the area of GCP (good clinical practice) and GVP (Good pharmacovigilance practices) preferably; in national and international regulations