About the Client
Our client is a fast-growing biotechnology company dedicated to developing next-generation therapies that transform patients' lives. With state-of-the-art facilities across Europe and the U.S., they combine science, innovation, and technology to deliver breakthrough treatments in oncology and immunology. The site hosting this project focuses on advanced therapy medicinal products (ATMPs) and operates under stringent GMP standards to ensure the highest level of product quality and patient safety.
Job Description
We are seeking a Quality Officer to support GMP manufacturing activities on a six-month project. The role focuses on maintaining product quality and compliance across ATMP production, documentation, and release processes. You will act as a key QA representative across manufacturing, supply chain, and SAP-related operations, ensuring adherence to regulatory standards and continuous improvement of quality systems.
Responsibilities
- Review and approve manufacturing batch records
- Oversee deviations, CAPAs, and change controls to ensure full GMP compliance
- Act as QA representative for manufacturing and supply chain activities
- Support review and release of products within SAP, maintaining complete audit trails
- Manage QA documentation related to products, logistics, and quality events
- Approve and maintain SOPs and procedures within assigned functional areas
- Participate in quality investigations and provide recommendations for improvement
- Identify opportunities for process efficiency and continuous improvement initiatives
Requirements
- Degree in Biology, Biotechnology, Chemistry, or related life sciences discipline
- 3-5 years' experience in a GMP-regulated quality assurance or manufacturing role
- Hands-on experience with ATMP, biologics, or pharmaceutical production preferred
- Strong working knowledge of cGMP documentation and QA systems
- Experience managing deviations, CAPAs, and change control processes
- Familiarity with SAP and electronic quality systems desirable
