Quality Control Manager in Advanced Therapy Medicinal Product

08 ago - Modena
Evote

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.
Manage day‑to‑day QC lab operations, including raw materials, in‑process, and final product testing
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
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
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)
Ability to analyze data, summarize results, and identify solutions
Good knowledge of Microsoft Office applications
English intermediate level is required (written and spoken)
Good verbal, written, and interpersonal communication skills

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