We are currently looking for a Senior Clinical QA Director who is highly motivated and experienced to lead and strengthen our Clinical Quality Assurance department. Join our dynamic team and work from anywhere in Germany remotely.
Your Mission:
- Overseeing the CQA department and leading a dedicated team of professionals
- Clinical Quality Assurance planning, implementation, and continuous improvement across all involved business areas
- Managing budgets and monitoring expenditures for CQA functions, as well as supervising line reports and contracted external staff
- Creating and implementing an internal and external GCP audit program
- Assisting with GCP-related regulatory inspections and third-party audits
- Quality Key Performance Indicators (KPIs) reporting within CQA
- Coordination of GCP vendor qualification
- Working in close collaboration with the Quality Management Systems department to guide and support the harmonisation and continuous improvement of GCP compliant QMS across sites
Your Profile:
- A bachelor's degree in natural sciences, engineering, or quality management
- 10+ years of experience working or consulting in Clinical Quality Assurance for mid-size life sciences companies, preferably in both early-stage and late-stage clinical development environments
- Proven leadership experience in implementing QMS in a GCP-regulated environment
- Thorough understanding of GCP requirements for drug development (ICH-E6(R2)) and industry QM standards (ISO 9000 series)
- An understanding of GMP and GLP requirements is advantageous
- Previous experience interacting with regulatory agencies in charge of GCP compliance (e.g., FDA, PEI)
- Proven ability to innovate business processes and implement solutions while leading cross-functional teams
- Excellent change management skills and strong interdisciplinary and cross-cultural communication skills in English; German language proficiency is a plus
