Quality Control Manager in Advanced Therapy Medicinal Product

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dml11

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 testingLead analytical method qualification, validation, and transferOversee analytical methods including flow cytometry, qPCR/ddPCR, and cell-based assaysEnsure timely execution and review of testing to support batch releaseManage external contract workers, ensuring outsourced QC testing operations are performed as required and within the planned timeframeAuthor, review and approve technical reports and QC documentationQC data collection and analysisEnsure GMP compliance, including handling deviations, OOS/OOT, CAPAs,



and change controlLead and develop QC team membersOversee laboratory equipment qualification and environmental monitoringSupport regulatory inspections and filingsProvide support to perform internal auditsRepresent QC team at technical meetings presenting and discussing resultsPromote and maintain a high level of GMP awareness and complianceQualifications and experience:Degree in Biology, Biotechnology, Pharmacy, or related field; PhD preferred5+ 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 methodsAbility to analyze data, summarize results, and identify solutionsExcellent knowledge of current GxP guideline and ATMP regulationsStrong leadership and communication skillsPositive, team player and problem-solving attitudeAccurate, with excellent prioritiz

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7dml11