Quality Control Manager in Advanced Therapy Medicinal Product

Evotec; Modena; In loco; EUR 50.000 - 75.000; Tempo pieno

Descrizione del lavoro

Evotec is seeking an experienced Quality Control (QC) Manager – ATMP in Modena, Italy. The role involves leading QC laboratory operations for advanced therapy medicinal products, ensuring compliance with GMP standards, and timely release of therapies.

The ideal candidate has over 5 years of experience in QC, especially in ATMP. Strong leadership, communication skills, and expertise in analytical methods are essential. A degree in Biology or related fields is required, with a PhD preferred.

Competenze

• 5+ years of QC experience in ATMP.
• Relevant previous experience as QC manager.
• Intermediate English level required.

Mansioni

• Manage day-to-day QC lab operations.
• Lead method qualification, validation, and transfer.
• Ensure GMP compliance and oversee lab equipment qualification.
• Support regulatory inspections and audits.

Conoscenze

cytofluorimetry expertise

biochemistry

microbiological methods

molecular biology methods

cell culture methods

data analysis

GxP guidelines knowledge

leadership skills

communication skills

Formazione

Degree in Biology, Biotechnology, Pharmacy, or related field

PhD preferred

Strumenti

Microsoft Office applications

Descrizione del lavoro

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 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.

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