Senior Quality Control Manager in GMP Analytics | Biologe (m/w/d)
RHEACELL GmbH & Co. KG
Job Summary
This is a critical, full-time role for a Senior Quality Control Manager in GMP Analytics at RHEACELL, a biopharmaceutical leader in innovative ABCB5-positive mesenchymal stem cell therapies (ATMPs). Based in Heidelberg, the manager will be responsible for ensuring the validation of analytical test procedures and conducting equipment qualifications, including the creation and review of corresponding plans and reports. Day-to-day work involves rigorous adherence to GMP standards, encompassing the creation and review of SOPs, risk analyses, and specifications for quality control. The role requires planning and coordinating quality tests, managing CAPA procedures, investigating deviations, and handling Change Control and OOS processes. Candidates must possess a Master's degree in Biosciences (preferably a PhD) and at least five years of relevant experience in a GMP-regulated pharmaceutical environment, coupled with expert knowledge of flow cytometry, ELISA, and qPCR. This position offers the opportunity to lead junior staff and contribute to late-stage drug development within a growing, innovative company.
Required Skills
Education
Completed Master's degree in Natural Sciences (Biosciences); ideally supplemented by a PhD
Experience
- Minimum 5 years of relevant professional experience in Quality Control within a GMP-regulated pharmaceutical environment
- Comprehensive experience in analytical method validation, equipment qualification, and SOP creation
- Professional experience handling inspections and audits
- Experience in technical leadership and support of junior QC managers and laboratory staff
Languages
Additional
- Location constraint: Heidelberg, Germany; Structured and quality-conscious working style; Strong communication and decision-making competence
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