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.