Director QC Processes & Systems | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This senior leadership role, based in Mainz, Germany, focuses on implementing and managing globally harmonized Quality Control (QC) systems and processes across multiple international sites. The Director will be responsible for aligning critical QC procedures, such as Out-of-Specification (OOS) management, QC documentation, SAP modules, and defining global Key Performance Indicators (KPIs). Day-to-day activities include directly leading a team of global business process owners, technically guiding local process owners, defining best practices, and acting as the Head of Quality Control for central processes, ensuring compliance with German AMWHV §12. The ideal candidate must possess over 10 years of GMP QC experience, including significant leadership tenure, and proven expertise in managing centralized teams and successfully navigating regulatory audits and inspections, making this a pivotal position for driving global quality standards and operational efficiency.
Required Skills
Education
Not specified
Experience
- 10+ years of experience in GMP Quality Control
- 5 years as QC Head
- Proven track record of success in GMP QC
- Experience in setting up and leading centralized teams within global QC
- Extensive experience in managing audits and inspections, including interactions with regulatory authorities (e.g., FDA)
- Experience in implementing and managing globally harmonized systems, KPIs, and processes
Languages
Additional
- Responsibility as Head of Quality Control (as per German AMWHV §12) for central processes
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