Quality Control Manager in Advanced Therapy Medicinal Product

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ewbur

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ewbur