Quality Control Manager in Advanced Therapy Medicinal Product

Evotec

Modena, Italy

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 documentation;
QC data collection and analysis;
Ensure GMP compliance, including handling 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.

Qualifications and experience:

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

Required Skills & Abilities:

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;
Commitment to the assigned deadlines and ability to deliver them tightly;
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.