Quality Control Manager (Qualified Person)
Air Liquide Medical Ltd. NV and Air Liquide Healthcare Netherlands provide healthcare professionals and patients with solutions that contribute to our mission of protecting vulnerable lives. We are constantly inventing and developing solutions for healthcare facilities. In the Hospital Care (Belux) business, our employees serve more than 7,500 hospitals and clinics every day, supplying them with oxygen and other medical gases. In the Homecare business (Belux), our employees take care of the respiratory treatment at home of, among others, more than 40,000 patients.
How will you CONTRIBUTE and GROW?
You take full responsibility as Qualified Person (QP) for our European production facility located in Schelle, as well as for two other sites (with limited activity) managed remotely. As the key Quality contact on site, you are responsible for batch release, ensuring strict adherence to Good Manufacturing Practice (GMP) guidelines and regulatory requirements.
In this role, you drive key pharmaceutical projects on-site, including the validation of new manufacturing processes, new analytical methods, and the introduction of new products. You lead and empower a dedicated team of 7 people (Backup QP, QC Officer, Lab Team Leader, Lab Technicians…) who assist you in daily release activities, deviation management, Out of Specification (OOS) investigations, customer complaints, self inspections, as well as equipment/instrument qualification and process validation.
Main tasks
Qualified Person Responsibilities & Batch Release
Act as the Qualified Person (QP) for the manufacturing site in Schelle, ensuring full regulatory compliance and timely batch release of medicinal products (medical gases filled in cylinders and cryogenic vessels).
Act as the Qualified Person (QP) remotely for the filling of road tankers with cryogenic medicinal gases across two additional Belgian sites.
Oversee quality control activities and certify that each production batch has been manufactured and checked in accordance with GMP and Marketing Authorizations.
Team Leadership & Operational Management
Manage, coach, and guide a team of 7 team members (including Backup QP, QC officer, Lab Technician reporting to the lab team Leader).
Oversee daily operations related to batch release, deviations, Out of Specification (OOS) investigations, CAPAs, self inspections and product quality complaints.
Pharma Projects & Validations
Lead and oversee site pharma projects: validation of new manufacturing processes, implementation and transfer of new analytical methods, and site launch of new products for about 10 countries in Europe.
Supervise qualification and calibration programs for laboratory equipment and instruments.
Continuous Improvement & Compliance
Ensure continuous compliance with local and European pharmaceutical regulations and guidelines.
Participate in internal and external audits & inspections (from health authorities, notified bodies, corporate, customers) and drive continuous quality improvement initiatives across the site.
Work closely with the Pharmaceutical Affairs Director and internal stakeholders (operations but also sales department) as well as with several European affiliates to align quality objectives with corporate and business strategy.
Are you a MATCH?
Profile
Education & Experience
Master's degree in Pharmacy / Pharmaceutical Sciences with QP number.
8 to 10 years of experience as a Qualified Person (QP) in a pharmaceutical manufacturing and QC environment.
Technical & Project skills
Proven experience in batch release, method validation, process validation, and instrument qualification.
Strong expertise in GMP, GLP, deviation management, and root-cause analysis (OOS/CAPA).
Demonstrated track record in leading site project initiatives and the implementation of new products and analytical methods.
Leadership & Personal skills
Proven leadership and people management skills with an empowering, collaborative approach.
Team player with strong communication, social, and interpersonal skills.
Highly structured, accurate, and stress-resistant with a strong pragmatic and problem-solving mindset.
Analytical mindset with a good "helicopter view" to balance operational urgency and long-term project goals.
Languages
Fluent in Dutch and English (written and spoken)
Knowledge of French is a strong asset (nice to have)
Our Differences make our Performance
At Air Liquide, we are committed to build a diverse and inclusive workplace that embraces the diversity of our employees, our customers, patients, community stakeholders and cultures across the world.
We welcome and consider applications from all qualified applicants, regardless of their background. We strongly believe a diverse organization opens up opportunities for people to express their talent, both individually and collectively and it helps foster our ability to innovate by living our fundamentals, acting for our success and creating an engaging environment in a changing world.
