Quality Control Manager in Advanced Therapy Medicinal Product
Pubblicato il 10-09-2026 - Evote in Modena
Position Summary
We are seeking an experienced Quality Control (QC) Manager – ATMP to lead QC laboratory operations supporting GMP manufacturing of advanced therapy medicinal products. This role is critical in ensuring timely and compliant release of patient‑specific therapies and maintaining the highest standards of quality and regulatory compliance.
Key Responsibilities
- Manage day‑to‑day QC lab operations, including raw materials, in‑process, and final product testing
- Lead analytical method qualification, validation, and transfer
- Oversee analytical methods including flow cytometry, qPCR/ddPCR, and cell‑based assays
- Ensure timely execution and review of testing to support batch release
- Manage external contract workers, ensuring outsourced QC testing operations are performed as required and within the planned timeframe
- Author, review and approve technical reports and QC documentation
- QC data collection and analysis
- Ensure GMP compliance, including handling deviations, OOS/OOT, CAPAs, and change control
- Lead and develop QC team members
- Oversee laboratory equipment qualification and environmental monitoring
- Support regulatory inspections and filings
- Provide support to perform internal audits
- Represent QC team at technical meetings presenting and discussing results
- Promote and maintain a high level of GMP awareness and compliance
Qualifications and experience
- Degree in Biology, Biotechnology, Pharmacy, or related field; PhD preferred
- 5+ years of QC experience in ATMP (cell therapy and gene therapy preferred)
- Relevant previous experience as QC manager
Required Skills & Abilities
- Solid expertise in cytofluorimetry (data acquisition and analysis)
- Strong expertise in biochemistry, microbiological, molecular biology and cell culture methods
- Ability to analyze data, summarize results, and identify solutions
- Excellent knowledge of current GxP guideline and ATMP regulations
- Strong leadership and communication skills
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