Quality Control Manager in Advanced Therapy Medicinal Product

## Quality Control Manager in Advanced Therapy Medicinal ProductApplylocations: Modenatime type: Full timeposted on: Posted 2 Days Agojob requisition id: JOB ID-14398 **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

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