Quality Control Manager in Advanced Therapy Medicinal Product

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.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.