Director of QC Processes and Systems | Pharmacist (m/w/d)
BioNTech SE
Job Summary
This senior leadership role focuses on implementing and managing globally harmonized Quality Control (QC) systems and processes across multiple international sites, based in Mainz, Germany. The Director is responsible for defining best practice processes, developing globally applicable Key Performance Indicators (KPIs) for QC departments, and managing critical centralized processes such as shelf life extension and reference substance management. A core function involves directly leading a team of global business process owners while technically guiding local owners to ensure comprehensive process alignment across all QC locations. Success in this position requires a proven track record of leadership, expert knowledge of GMP, global regulatory frameworks, and extensive experience managing audits and inspections, including successful interactions with regulatory bodies like the FDA. The ideal candidate will drive the development of efficient, robust, and scalable QC operations globally.
Required Skills
Education
Not specified
Experience
- 10+ years of experience in GMP Quality Control
- 5 years as a QC Head
- Proven track record of success
- Expertise in setting up and leading centralized teams within global QC
- Experience in implementing and managing globally harmonized systems, KPIs, and processes
- Extensive experience in managing audits and inspections
Languages
Additional
- Strong knowledge of country-specific regulations and global regulatory frameworks, ensuring compliance with standards across multiple regions.
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