Quality Person in Plant

About the role

The Quality Person in Plant will provide quality oversight for the production of personalized cell therapies in a sterile GMP environment. Working on a rotating 7‑day shift schedule, you will support both clinical and commercial manufacturing activities while ensuring compliance with cGMP standards.

Key responsibilities

• Perform real‑time review of process documentation, batch records and release activities.
• Conduct periodic quality checks, audits and internal housekeeping audits covering process, documentation and manipulations.
• Support investigation, input and review of manufacturing deviations, CAPAs, change controls and complaints.
• Collaborate with site personnel to resolve manufacturing issues and provide guidance on compliance.
• Review and approve manufacturing procedures and batch records.
• Assist regulatory inspections and audits by maintaining inspection readiness.

Required profile

• Bachelor’s degree in Science, Engineering or a related technical discipline, or equivalent industry experience.
• Minimum 2 years of relevant experience, preferably in an aseptic manufacturing facility supporting quality assurance or clinical cell‑therapy production.
• Proficiency in Dutch and/or English with strong written and oral communication skills.

Required skills

• GMP / cGMP compliance
• Aseptic manufacturing processes
• Quality audits and inspections
• CAPA management
• Change control procedures
• Batch record review and approval

What we offer

• Indefinite contract with a competitive salary and comprehensive benefits package.
• Four‑day work week followed by four days off, supporting work‑life balance.
• Extensive in‑house training and opportunities for personal and professional growth.
• International, diverse team and chance to work on innovative cell‑therapy projects.