Quality Person in Plant (QPIP) – GMP Cell Therapy Production

About the role

The Quality Person in Plant (QPIP) provides quality oversight for the production of personalized cell therapies in a sterile GMP environment. You will work closely with operators on the shop floor to ensure every step meets the highest quality and compliance standards.

Key responsibilities

• Perform on‑the‑floor witnessing, acting as the first point of contact for operators on quality, process discipline, and documentation.
• Monitor real‑time compliance with procedures and GMP requirements, ensuring correct interventions.
• Conduct periodic quality checks, audits, and promote compliance to reduce non‑conformities.
• Review production procedures and batch records, leading the operational batch release process.
• Identify, assess, and escalate deviations while prioritising patient safety.
• Support logging, investigation, and assessment of deviations, CAPAs, change controls, and complaints.
• Review and maintain process documentation in line with safety policies, quality systems, and cGMP.
• Take on additional responsibilities as needed to maintain facility‑wide quality standards.

Required profile

• Bachelor’s degree in Life Sciences or equivalent.
• Minimum 2 years experience in an aseptic manufacturing environment within pharma or biotech.
• Fluent English (written and spoken); Dutch is an asset.
• Structured, detail‑oriented approach with strong adherence to procedures.
• Ability to make well‑considered decisions while maintaining compliance.
• Solution‑oriented mindset with clear, adaptable communication skills.

Required skills

• Knowledge of cGMP regulations.
• Familiarity with FDA and EU guidelines.
• Experience with aseptic manufacturing processes.
• Proficiency in batch record review and deviation handling.