Your Role
As a GMP Compliance & Quality Assurance Expert, you will play a key role in helping our clients maintain the highest standards of quality and regulatory compliance. You will contribute to projects that ensure processes, systems, and products meet international GMP regulations and are inspection-ready.
Your role may include:
- Supporting QA operations such as deviation handling, CAPA management, change control, and batch record review
- Conducting compliance assessments and preparing clients for regulatory inspections and audits.
- Coordinating quality activities across departments and ensuring alignment between stakeholders.
- Leading or supporting project management for GMP compliance initiatives, from planning to execution and follow-up.
- Guiding system improvements, implementing best practices, and embedding a culture of quality.
- Collaborating with cross-functional teams (R&D, Manufacturing, QC, Engineering) to strengthen GMP processes.
- Acting as a consultant to translate complex regulatory requirements into clear, practical solutions.
- Mentoring junior colleagues and contributing to internal knowledge sharing.
Qualities
- You have a Master of Science (Chemistry, Biomedical Sciences, Bio-Engineering, Pharmaceutical Sciences, etc.) or a Professional Bachelor of Science (Chemistry, Lab Technology, etc.) or equivalent through experience
- You bring at least 5 years of experience in a GMP-regulated environment (pharmaceuticals, biotech, ATMPs, medical devices, or related).
- You have strong knowledge of GxP, Quality Management Systems, audits/inspections, deviation & CAPA management, change control, and/or GMP compliance frameworks.
- You speak Dutch and English fluently, French is a plus
Additional assets
- You can work in a team as well as individually
- You have an eye for detail and quality
- You are a strong communicator
- You are customer-oriented and have a consultancy mindset
- You are open to sharing expertise with junior colleagues and contributing to knowledge growth.