Quality Director

About the role

We are seeking a Quality Director to lead our Quality department at our Mariakerke site in Belgium. The role combines strategic leadership with hands‑on oversight of quality systems, ensuring compliance and driving continuous improvement across our CDMO operations.

Key responsibilities

• Develop and implement quality policies and procedures, especially for investigational medicinal products (IMPs).
• Lead the Quality department, including the engineering subgroup, and ensure staff training and development.
• Supervise and actively participate in internal and external audits, guaranteeing regulatory compliance.
• Analyse quality data and report findings to the Management Team.
• Collaborate with GMP Production, R&D (formulation), and Analytical departments to resolve quality issues and implement improvements.
• Work with corporate functions to shape strategy and processes for the Ghent site within the Ardena group.
• Align business objectives with legal quality requirements in the pharmaceutical industry.
• Drive the integration of artificial intelligence into global quality systems, acting as a visionary leader for AI adoption locally and globally.
• Participate as a member of the local Management Team, reporting to the Chief Quality Officer.

Required profile

• Minimum 7 years of experience in quality assurance/quality control within the pharmaceutical industry, including leadership responsibilities.
• Master’s degree in Pharmaceutical Sciences or a related field.
• In‑depth knowledge of GMP regulations and quality standards for IMPs.
• Proven experience managing cross‑functional teams and driving continuous improvement.
• Strong analytical skills and ability to interpret quality data.
• Experience with audit planning and execution (internal and external).
• Ability to work strategically with corporate functions and senior management.
• Visionary mindset for implementing AI technologies in quality processes.

Required skills

• Good Manufacturing Practice (GMP)
• Quality Management Systems (QMS)
• Investigational Medicinal Product (IMP) regulations
• Data analysis for quality metrics
• Artificial Intelligence (AI) integration in quality processes