Quality Control Manager in Advanced Therapy Medicinal Product

Overview  Experteer Overview As 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 efits   Manage day-to-day QC lab operations across 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 and outsourced QC testing within planned time frames
Author, review and approve technical reports and QC documentation
QC data collection and analysis
Ensure GMP compliance including 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
Responsabilità   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
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 identify solutions
Excellent knowledge of current GxP guideline and ATMP regulations
Strong leadership and communication skills
Positive, team player and problem-solving attitude
Accurate, with excellent prioritization and organization skills
Good knowledge of Microsoft Office applications
English intermediate level is required (written and spoken)
Good verbal, written, and interpersonal communication skills
Ability to work independently, maintaining a team-focused attitude
Open-minded and problem-solving attitude
Requisiti fondamentali
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