Quality Control Manager in Advanced Therapy Medicinal Product

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d496l

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7d496l