Head of Inspection Management Quality Operations | Leitung Inspektionsmanagement (m/w/d) Quality Operations
Biotest AG
Job Summary
This leadership role involves overseeing and enhancing the entire inspection management system, focusing on national and international regulatory inspections (GMP/GDP) and customer audits. The successful candidate will act as the lead escort for these inspections, ensuring strategic alignment and continuous improvement of processes within a GMP environment. Key responsibilities include coordinating inspections, ensuring timely certification, managing corrective action plans, and proactively communicating with authorities, including the FDA. The role also involves leading supplier audits and internal self-inspections to maintain compliance and identify areas for improvement. This position is ideal for a professional with a strong background in life sciences or engineering, extensive experience in quality operations, and excellent communication skills in both German and English.
Required Skills
Education
Degree in Biology, Chemistry, Pharmacy, Medicine, or a related engineering science. Doctorate is a plus.
Experience
- Several years of experience in accompanying inspections by national and international authorities
- Several years of experience in collaborating with customers in a GMP environment
Languages
Additional
- Not specified
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