Quality Control Manager in Advanced Therapy Medicinal Product

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7mrv36

Quality Control Manager in Advanced Therapy Medicinal ProductApplylocations: Modenatime type: Full timeposted on: Posted 2 Days Agojob requisition id: JOB ID-14398
Dato l'elevato interesse per questa posizione, la preghiamo di candidarsi tempestivamente se il suo profilo è in linea con il ruolo.
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 anal

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7mrv36