Quality Director

About the role

Ardena is seeking a Quality Director to lead its Quality department at the Ghent site in Mariakerke, Belgium. The role combines strategic oversight with hands‑on operational responsibilities to ensure the highest quality standards for pharmaceutical products.

Key responsibilities

• Develop and implement quality policies and procedures, especially for investigational medicinal products (IMPs).
• Lead the Quality department, including the engineering subgroup, and oversee training and development.
• Supervise and participate in internal and external audits to ensure regulatory compliance.
• Analyze quality data and report findings to the Management Team.
• Collaborate with GMP Production, R&D formulation, and analytical teams to resolve quality issues and drive improvements.
• Work with corporate functions to shape site strategy and processes.
• Align business objectives with legal quality requirements in the pharmaceutical industry.
• Drive the integration of artificial intelligence into global quality systems and processes.

Required profile

• Minimum 7 years of experience in Quality, with proven leadership experience.
• Master’s degree in Pharmaceutical Sciences.
• Thorough knowledge of pharmaceutical quality regulations and standards.

Required skills

• Good Manufacturing Practice (GMP) expertise.
• Quality Management Systems (QMS) implementation.
• Application of Artificial Intelligence (AI) in quality processes.