Public summary
A senior Quality Assurance Manager role in the biotechnology sector, focusing on overseeing quality and regulatory compliance for external pharmaceutical manufacturing activities related to cell therapies. The role involves supporting technical transfers, aligning manufacturing processes, investigating quality issues, maintaining global quality management systems, and managing audits and regulatory inspections. Requires experience in GMP-regulated pharmaceutical or biotech environments, knowledge of ATMP operations, and strong communication skills in an international context. Position offers flexible remote work and encourages diversity and professional development.
Location and work setup
- Location
- Bergisch Gladbach
- Remote status
- Hybrid
- German requirement signal
- No German Required Detected
- Detected job language
- English
Responsibilities
Lead Quality Assurance oversight for external pharmaceutical manufacturing related to cell therapies. Ensure compliance with global quality and regulatory requirements. Support technical transfers and alignment of internal and external manufacturing. Investigate and resolve quality-related issues impacting product quality and patient safety. Contribute to development and maintenance of the Global Quality Management System. Collect and report Quality KPIs, perform Quality Management Reviews, and author Annual Product Quality Reviews. Support third-party qualifications, audits, regulatory inspections, and customer audits. Review regulatory documentation as needed.
Qualifications
University degree in Pharmaceutical Sciences, Biology, Biotechnology, Chemistry, Biochemistry, Engineering or related field. Several years of operational Quality Assurance experience in GMP-regulated pharmaceutical or biotechnology settings, preferably with Pharma CDMOs. In-depth knowledge of global GMP/GDP regulatory requirements and ATMP operations. Experience with technical transfers, QA oversight of external manufacturing partners, third-party management, and regulatory inspections. Experience developing and maintaining Pharma Quality Management Systems compliant with FDA, EMA, ICH, and local requirements. Excellent communication and collaboration skills across international and cross-cultural teams. Leadership experience is desirable.