Head of Quality Control, Biotechnological Drug Substance Manufacturing | Biologe (m/w/d)
Richter BioLogics GmbH & Co. KG
Job Summary
This leadership role involves strategically and operationally managing the Quality Control department in Hannover for a leading biotechnology company focused on biopharmaceutical drug substance manufacturing under GMP conditions. The Head of QC is responsible for the release activities of products, ensuring full compliance with AMWHV and EU-GMP regulations, and harmonizing processes across sites. Key responsibilities include the technical and disciplinary leadership of the QC team, managing capacity planning for CDMO projects, and representing QC in customer meetings, audits, and authority inspections. The ideal candidate holds a PhD in Biology or a related natural science, possesses extensive leadership experience in pharmaceutical QC within a GMP environment, particularly with biotechnological drug substances, and demonstrates strong expertise in analytical methods and regulatory requirements (Ph. Eur., USP, CFR 21, ICH). This position offers a challenging role in a dynamic market with long-term prospects, flexible working hours, and competitive compensation.
Required Skills
Education
Doctorate (PhD) in Biology, Biotechnology, or a related natural science field
Experience
- Several years of leadership experience in pharmaceutical Quality Control within a GMP environment
- Experience with biotechnological drug substances is desirable
- Experience in optimizing and validating biological test methods
- Experience with digital systems like LIMS and SAP is desirable
Languages
Additional
- Willingness to relocate to within 150 km of one of the company's sites (Hamburg, Bovenau, or Hannover) to receive relocation assistance.
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