Quality Control Manager in Advanced Therapy Medicinal Product

Evotec (Modena) Srl

📍 Modena, Emilia-Romagna, Italy

Full time Operations Specialties Managers

Job Description

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 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 d...

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