Quality Control Manager (Qualified Person)

About the role

Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands are hiring a Quality Manager and Qualified Person (QP) for its Benelux Pharmaceutical / Quality Department, reporting directly to the Pharmaceutical Affairs Director. You will take full responsibility as QP for the European production facility in Schelle and for two other Belgian sites with limited activity managed remotely. As the key quality contact on site, you ensure batch release complies with GMP and regulatory requirements.

Key responsibilities

• Act as QP for the Schelle site and for the remote filling of road tankers at two other Belgian sites, ensuring timely batch release of medicinal products (medical gases in cylinders and cryogenic vessels).
• Certify that each batch was manufactured and checked in line with GMP and marketing authorisations.
• Manage and coach a team of 7 people (Backup QP, QC officer, Lab Team Leader, Lab Technicians) and oversee batch release, deviations, OOS investigations, CAPAs, self-inspections and product quality complaints.
• Lead site pharma projects: validation of new manufacturing processes, transfer of new analytical methods and launch of new products for about 10 European countries.
• Supervise qualification and calibration of laboratory equipment and instruments.
• Ensure compliance with local and European pharmaceutical regulations, take part in internal and external audits and inspections, and work with the Pharmaceutical Affairs Director, operations, sales and European affiliates.

Required profile

• Master's degree in Pharmacy or Pharmaceutical Sciences with a QP number.
• 8 to 10 years of experience as a Qualified Person in a pharmaceutical manufacturing and QC environment.
• Fluent Dutch and English; knowledge of French is a strong asset.

Required skills

• Batch release, method validation, process validation and instrument qualification.
• GMP, GLP, deviation management and root-cause analysis (OOS/CAPA).
• Experience leading site projects and implementing new products and analytical methods.
• Leadership, communication and problem-solving skills.