Manager, Operational Quality Assurance - Supplier Qualifications | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This critical role in Mainz, Germany, focuses on operational quality assurance within the Supplier and Materials Lifecycle Management team. The Manager acts as the primary QA point of contact, providing oversight for suppliers, service providers, and contract laboratories. Daily responsibilities include performing and supporting internal and external audits, leading supplier and contract lab qualifications, and negotiating quality agreements. The successful candidate will participate actively in building a robust Material Supply Chain and leading critical decision-making processes concerning phase-appropriate quality compliance. Key qualifications include a university degree in a scientific field (e.g., Pharmacy, Chemistry, Biology), several years of relevant experience in quality assurance or project management, ideally within the biotech or pharmaceutical sectors. A strong quality mindset, profound knowledge of EU GMP and FDA regulations, and fluent communication skills in both German and English are mandatory for effective stakeholder alignment in this dynamic environment.
Required Skills
Education
University degree in Chemistry, Pharmacy, Biology, Molecular Biology, or other scientific area
Experience
- Several years of work experience in quality assurance, quality oversight, or project management
- Professional experience, ideally in a biotech or pharmaceutical company
- Experience in the manufacturing of investigational medicinal products for clinical studies of phase I to III
Languages
Additional
- Willingness to travel for audits
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