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
Positive, team player and problem‐solving attitude
Accurate,

Quality Control Manager in Advanced Therapy Medicinal Product

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