Group Lead Quality Assurance Non-Plasma and External Production | Gruppenleitung (m/w/d) Quality Assurance non-Plasma und externe Produktion
Biotest AG
Job Summary
This leadership role involves managing and developing a Quality Assurance team focused on non-plasma products and external production oversight. The Group Lead ensures company-wide compliance with GMP and GDP regulations concerning the qualification and monitoring of external suppliers and production sites. Key responsibilities include leading supplier audits and self-inspections as a Lead Auditor, optimizing quality systems related to supplier management, and drafting quality agreements. The successful candidate will drive process and quality improvements, manage related projects, and act as a Subject Matter Expert during regulatory and customer inspections. This position requires strong professional experience in the pharmaceutical GMP/cGMP sector, proven team leadership skills, and the ability to travel internationally for audits (approximately 15%). Fluency in both German and English is mandatory.
Required Skills
Education
Completed university degree in Natural Sciences (Biology, Chemistry, Medicine, or Pharmacy) or relevant engineering disciplines
Experience
- Extensive practical experience in the pharmaceutical GMP and cGMP sector
- Extensive practical experience regarding inspections by national and international authorities
- Several years of experience in leading teams
- Professional experience in interdisciplinary project work, ideally in a leading function
Languages
Additional
- International travel readiness (approx. 15%) for supplier audits
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