GMP Compliance & Quality Assurance Expert

About the role

We are seeking a GMP Compliance & Quality Assurance Expert to support our customers in meeting regional and global GMP regulations. You will work closely with client teams to ensure processes, systems, and products are inspection‑ready and aligned with the highest quality standards.

Key responsibilities

• Support QA operations including deviation handling, CAPA management, change control, and batch record review.
• Conduct compliance assessments and prepare clients for regulatory inspections and audits.
• Coordinate quality activities across departments, ensuring stakeholder alignment.
• Lead or assist project management for GMP compliance initiatives from planning through execution.
• Guide system improvements, implement best practices, and foster a culture of quality.
• Collaborate with R&D, Manufacturing, QC, and Engineering to strengthen GMP processes.
• Act as a consultant, translating complex regulatory requirements into practical solutions.
• Mentor junior colleagues and contribute to internal knowledge sharing.

Required profile

• Master’s or Professional Bachelor’s degree in Chemistry, Biomedical Sciences, Bio‑Engineering, Pharmaceutical Sciences, or related field, or equivalent experience.
• Minimum 5 years of experience in a GMP‑regulated environment (pharma, biotech, ATMPs, medical devices, etc.).
• Fluent in Dutch and English; French is a plus.
• Strong communication skills and a customer‑oriented, consultancy mindset.

Required skills

• GxP knowledge
• Quality Management Systems (QMS)
• CAPA management
• Change control processes
• Batch record review
• Regulatory audit and inspection preparation