Head of Inspection Management Quality Operations | Leitung Inspektionsmanagement (m/w/d) Quality Operations
Biotest AG
Job Summary
This pivotal role involves leading and advancing the 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 and audits, ensuring timely certification, and managing corrective action plans. The role also involves proactive communication with regulatory authorities, including the FDA, and leading supplier audits and internal self-inspections. This position is ideal for a professional with a strong background in life sciences or engineering, extensive experience in GMP/GDP environments, and excellent communication skills in both German and English.
Required Skills
Education
University degree in Biology, Chemistry, Pharmacy, Medicine, or a related engineering science. Doctorate is a plus.
Experience
- Several years of experience accompanying inspections by national and international authorities
- Several years of experience collaborating with customers in a GMP environment
Languages
Additional
- Not specified
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