Quality & Compliance Coordinator, Hoofddorp, Noord-Holland

The Company
Our client, a leading biopharmaceutical company specializing in innovative cell therapies. This company is at the forefront of developing ground-breaking cancer treatments, focusing on advanced immunotherapy solutions that help patients worldwide.

Role description:

• Ensure Quality Systems comply with regulations and policies.

• Oversee the MRB system, chair meetings, and manage communication.

• Manage Change Control, Deviation, and CAPA systems, including training and administration.

• Support multidisciplinary initiatives and Kite EU startup projects.

• Assist with regulatory inspections and audits.

• Maintain and approve cGMP documents.

• Review and approve system and procedure changes.

• Track, analyze, and report quality metrics for continuous improvement.

• Perform other related tasks as needed.

• Expert in GMP & Quality Systems (Change Control, CAPA, Audits, Deviations, MRB).

• Experience in Aseptic Manufacturing and regulatory compliance.

• Tech-Savvy – Proficient in MS Office & Quality Management Systems.

• Education: Bachelor’s in Chemistry, Microbiology, Engineering, or similar.

• Experience: 5+ years in Quality Assurance (GMP environment). ATMP experience is a plus.

• Skills: Strong communication, problem-solving, and ability to work independently.

Other Information 

If you are interested in joining a team that is shaping the future of medicine, apply now via the link or contact Sofia Alftan. 

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