The successful candidate will be responsible for implementing comprehensive quality management systems, ensuring GMP compliance, and managing all quality-related activities from construction through to facility handover and validation.
Establish and maintain project quality management systems aligned with pharmaceutical industry standards
Ensure all construction activities comply with Good Manufacturing Practice requirements and regulatory standards
Direct daily quality activities across all construction disciplines and contractors
Oversee quality documentation, IQ/OQ protocols, and validation master plans
Coordinate internal and external quality audits, regulatory inspections, and client assessments
Lead investigation and resolution of quality issues and deviations
Monitor subcontractor quality performance and compliance with project specifications
Deliver quality training programs for project teams and contractors
Degree in Engineering, Science, Quality Management, or related discipline
Minimum 8+ years in quality management roles on major construction / engineering projects
Proven experience in pharma facility construction quality management
Deep understanding of GMP, and Belgian/EU pharmaceutical regulations
Extensive experience with ISO 9001, quality management systems, and validation processes
Fluent English essential; Dutch/French advantageous
Qualified internal auditor with experience managing regulatory inspections
Professional quality qualification advantageous
Experience with cleanroom construction and controlled environment validation advantageous
Understanding of pharmaceutical engineering standards
