Deputy Head of Quality Assurance | Biologe (m/w/d)
RHEACELL GmbH & Co. KG
Job Summary
This role as Deputy Head of Quality Assurance in Heidelberg involves driving the quality framework for innovative, patent-protected stem cell therapeutics (ATMPs) currently in late-stage clinical trials. The successful candidate will be responsible for the comprehensive management of GMP documentation, including the creation, review, and approval of Standard Operating Procedures (SOPs) and work instructions. Daily tasks include planning and executing internal self-inspections and supplier audits, preparing for regulatory authority inspections, and conducting essential GMP training for staff. Furthermore, the role requires active participation in deviation management, CAPA, and Change Control processes, alongside contributing to risk analyses and validation/qualification efforts. Candidates must possess a scientific degree, significant experience in Quality Assurance, particularly with GMP and CMC knowledge, and proficiency in documentation systems. This is an opportunity to take on leadership responsibility and contribute to medical progress within a highly motivated, globally active team focused on 21st-century medicine.
Required Skills
Education
Completed scientific degree or comparable qualification
Experience
- Several years in Quality Assurance
- Professional experience with GMP and CMC knowledge (ideal)
- Experience in audit and inspection processes
- Initial leadership experience or willingness to assume leadership responsibility
Languages
Additional
- Full-time employment based in Heidelberg, Germany