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.