Quality Assurance Manager

We are looking for an experienced Quality Assurance Manager to support our clients in maintaining and improving their Quality Management Systems in regulated Life Sciences environments. The consultant will act as a key quality partner, driving compliance, audit readiness, and continuous improvement initiatives across the organisation.

• Manage and maintain the Quality Management System (QMS) in accordance with GMP/ISO standards
• Plan and lead internal and external audits; manage supplier qualification programs
• Handle deviations, non-conformances, CAPAs, and change control processes
• Review and approve SOPs, batch records, and other controlled documents
• Ensure compliance with applicable regulations (EU GMP, FDA, ICH guidelines)
• Act as key contact during regulatory inspections and health authority visits
• Train and coach operational teams on quality standards and drive continuous improvement

• Degree in pharmacy, life sciences, engineering, or equivalent
• Minimum 5 years of experience in a QA role within pharma, biotech, or medical devices
• In-depth knowledge of GMP regulations, ICH guidelines, and ISO standards (ISO 13485 is a plus)
• Proven experience with audits, CAPA management, and change control
• Strong leadership and communication skills
• Fluent in English; French and/or Dutch is a plus