Senior QA Manager Validation & Quality
On-site · Lund, Skåne, Sweden
Job Summary
Senior QA Manager Validation & Quality responsible for directing QA and validation activities across DS/DP manufacturing, reviewing validation documentation, and managing supplier quality and external partners to support regulatory inspections. Collaborates cross-functionally with CMC, Regulatory, Clinical and Supply Chain; drives continuous improvement of the Quality Management System; leads validation efforts through clinical and commercial stages; requires advanced degree and 10+ years in biopharma QA/validation; strong knowledge of FDA/EMA/ICH regulatory expectations and aseptic manufacturing; office in Lund, Sweden.
Required Qualifications
- Advanced degree (Ph.D. or M.Sc.) in Chemical Engineering, Chemistry, Pharmaceutical Sciences or a related discipline
- 10+ years of biopharmaceutical industry experience with a focus on QA, process development and validation
- Proven track record of leading validation activities for DS and DP through clinical and commercial stages
- Strong knowledge of aseptic manufacturing and biotechnology processes
- Deep understanding of regulatory requirements (FDA, EMA, ICH) related to manufacturing and validation
- Experience managing external partners and CDMOs/CMOs
- Experience of authority inspections (FDA, EMA) as presenter and/or coordinator
- Strong communication skills and the ability to influence across functions and organisational levels
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