PIC/S Compliance Expert

About the role

We are seeking a PIC/S Compliance Expert to guide hospital pharmacies and healthcare organisations through the journey to PIC/S compliance. You will ensure that infrastructure, processes and quality systems meet international Good Practice (GxP) standards, helping teams build inspection‑ready operations.

Key responsibilities

• Perform gap analyses to identify improvement areas.
• Support the design, implementation or revision of Quality Management Systems, including change control, deviations and CAPA procedures.
• Write and review qualification and validation protocols for equipment and controlled environments.
• Manage or support project delivery from planning to implementation and follow‑up.
• Develop training programmes and promote quality awareness within hospital teams.
• Assist with internal audits, inspection preparation and continuous improvement initiatives.
• Translate regulatory requirements into practical, hospital‑specific procedures.
• Collaborate with multidisciplinary teams to embed a sustainable quality culture.

Required profile

• Master of Science in Pharmaceutical Sciences, Biomedical Sciences, Bio‑Engineering, Chemistry or equivalent experience.
• Experience in a GxP or healthcare environment (hospital pharmacy, production, quality, validation).
• Strong understanding of quality systems, validation and compliance frameworks.
• Fluent in Dutch and English; French is a plus.

Required skills

• Gap analysis
• Quality Management System (QMS) development
• Qualification and validation protocol writing
• Project management
• Audit and inspection support
• Regulatory compliance translation

What we offer

• Opportunity to work on high‑impact compliance projects across leading hospitals.
• Collaborative, knowledge‑sharing environment.
• Professional development in GxP and regulatory affairs.