Quality Control Manager in Advanced Therapy Medicinal Product

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7den6w

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

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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 an

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7den6w