Manufacturing Quality Assurance Manager, Sterile Filling | 2* Manufacturing Quality Assurance Manager Sterile Filling (m/w/d)
Roche Diagnostics GmbH
Job Summary
This role involves actively supporting the supply of commercial and clinical pharmaceuticals by ensuring GMP-compliant and timely release of drug product batches, specifically focusing on sterile filling operations. The Manager will be responsible for compiling, reviewing, and evaluating manufacturing documents, and independently handling complex deviations, planned events (Changes, CAPA), and coordinating local Triage Teams for Root Cause Analysis (RCA). A key aspect of the position is acting as a GMP coach, promoting a Lean-Mindset culture, and driving continuous improvement across processes. The successful candidate requires a scientific degree, extensive experience in pharmaceutical quality assurance or manufacturing of sterile medicinal products, and fluent communication skills in both German and English to represent the site in global quality committees and regulatory interactions.
Required Skills
Education
Completed scientific degree (Bachelor/Master). Doctorate (PhD) is desirable.
Experience
- Several years of professional experience in the pharmaceutical industry in Quality Assurance or pharmaceutical manufacturing
- Professional experience in the manufacturing of sterile medicinal products
- Experience in handling complex deviations, technical changes, and CAPAs
- Experience in creating and reviewing Annual Product Quality Reports
- Professional experience with Lean and working in agile teams
- Technical leadership experience
Languages
Additional
- Deep knowledge of GMP, especially regarding sterile production and Annex 1 of the EU Guide to Good Manufacturing Practice ('Manufacture of Sterile Medicinal Products').
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