YOUR CONTRIBUTION
As a (Senior) Quality Assurance Manager GCP (m/f/d), you will be responsible for quality assurance within the R&D departments at Merz Therapeutics, in accordance with applicable regulations – including requirements for IT systems used in clinical trials. This is a full-time position, and your key responsibilities will include:
- Development and maintenance of systems and tools supporting quality processes
- Quality management in accordance with GCP and IT regulations (e.g., GAMP, 21 CFR Part 11)
- Planning and execution of audits, including reporting and CAPA follow-up
- Support with quality-related and IT-specific inquiries
- Ensuring compliance in global clinical development projects
- Preparation for and support during regulatory inspections
- Delivery of GCP training sessions as needed