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.

📌 Quality Control Manager in Advanced Therapy Medicinal Product (Modena)
🏢 Evotec
📍 Modena