Quality Control Manager In Advanced Therapy Medicinal Product

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ph3Overview /h3pExperteer OverviewAs QC Manager for ATMP, you ensure compliant, timely QC testing for GMP manufacturing of patient-specific therapies.
You will lead the QC lab, oversee method qualification and transfer, and manage external and internal stakeholders to support batch release and regulatory readiness.
You will drive GMP compliance, CAPAs, deviations, and change controls while developing a high-performing QC team.
This role offers impact in advancing innovative cell and gene therapies at Evotec.
/ph3Benefits /h3ulliManage day-to-day QC lab operations across raw materials, in-process, and final product testing /liliLead analytical method qualification, validation, and transfer /liliOversee analytical methods including flow cytometry, qPCR/ddPCR, and cell-based assays /liliEnsure timely execution and review of testing to support batch release /liliManage external contract workers and outsourced QC testing within planned timeframes /liliAuthor, review and approve technical reports and QC documentation /liliQC data collection and analysis /liliEnsure GMP compliance including deviations, OOS/OOT, CAPAs,



and change control /liliLead and develop QC team members /liliOversee laboratory equipment qualification and environmental monitoring /liliSupport regulatory inspections and filings /liliProvide support to perform internal audits /liliRepresent QC team at technical meetings presenting and discussing results /liliPromote and maintain a high level of GMP awareness and compliance /li /ulh3Responsabilità /h3ulliDegree in Biology, Biotechnology, Pharmacy, or related field; PhD preferred /lili5+ years of QC experience in ATMP (cell therapy and gene therapy preferred) /liliRelevant previous experience as QC manager /liliSolid expertise in cytofluorimetry (data acquisition and analysis) /liliStrong expertise in biochemistry, microbiological, molecular biology and cell culture methods /liliAbility to analyze data, summarize results, and identify solutions /liliExcellent knowledge of current GxP guideline and ATMP regulations /liliStrong leadership and communication skills /liliPositive, team player and problem-solving attitude /liliAccurate, with excellent prioritization and organization skills /liliGood knowledge of Microsoft Office applications /liliEnglish intermediate level is required (written and spoken) /liliGood verbal, written, and interpersonal communication skills /liliAbility to work independently, maintaining a team-focused attitude /liliOpen-minded and problem-solving attitude /li /ulh3Requisiti fondamentali /h3 /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bbx3f