Head of Quality Control & Analytical Science and Technology | Pharmacist (m/w/d)
Unknown Employer
Job Summary
This leadership role involves heading the Analytical Science & Technology (AS&T) and Quality Control (QC) departments at a manufacturing site in Marburg, focusing on biotechnology products. The successful candidate will be a visionary leader responsible for building and continuously improving analytical methods and quality control systems to ensure product quality and compliance with all regulatory and cGMP requirements. Day-to-day activities include strategic leadership, supervising routine testing of materials and finished products, monitoring deviations and CAPAs, and ensuring robust data integrity practices aligned with global standards (FDA, EMA, ICH). The role requires extensive experience in developing and validating analytical methods for complex molecules (like nucleic acids or proteins) within a cGMP environment, and a proven track record of successfully managing regulatory inspections and leading multidisciplinary teams to foster a culture of scientific and operational excellence.
Required Skills
Education
Degree in natural sciences, pharmacy, engineering, or a related field
Experience
- Extensive experience (10+ years) in developing, validating, and transferring analytical methods specific to biotech and clinical manufacturing
- Proven track record of successfully navigating regulatory inspections (e.g., FDA, EMA, PAI)
- Proven experience in effectively managing CMC-QC portfolios of multiple late-stage clinical products
- Extensive experience managing multidisciplinary teams in a high-stakes, fast-paced environment
Languages
Additional
- In-depth knowledge and hands-on experience of regulatory requirements for clinical and commercial production, including experience with FDA and EMA inspections.