Managing the Biological Critical Reagents (BCR) team managing the complete life cycle of Biological Critical Reagents.
Tactical planning and operational management of laboratory teams performing routine biochemical in‑process, release and stability testing, ensuring compliance with GMP and SHE requirements.
Oversee testing activities for environmental monitoring, biotechnological APIs, intermediates, and finished products.
Ensure the reliability of analytical methods and systems, and accountability for timely regulatory submissions and on time delivery of qualified Biological Critical Reagents.
Develop and train employees, embedding a “safety first, quality always” mindset across the organization.
Provide operational oversight and communicate status and risks within IPT and CoE.
Manage the execution of daily operational Quality Control activities including routine testing, incident and OOS management, and structured problem solving through daily walkthroughs and visual management.
Approval of BCR-related documentation, validation protocols and reports, change management, deviation handling, CAPA coordination, audit support, and adherence to approved methods and Quality Systems.
Manage workforce capacity and capability, recruitment, training, talent development, internships, and performance management in collaboration with HR.
Oversee the laboratory project portfolio and lead strategic projects from assessment through delivery.

Master’s or bachelor’s degree in Biochemistry, (Analytical) Chemistry, Biology, Pharmacy, or a related field.
Over 10 years of relevant experience, including people management, preferably within the pharmaceutical industry.
Strong expertise in pharmaceutical and biotechnological manufacturing, analytical chemistry, microbiology, GMP, validation, lean lab operations, SHE, and Quality Management.
Demonstrated ability to position Quality as a competitive advantage and to embed a strong quality culture across the Oss site.
Proven people leader with strong coaching, empowerment, and talent development capabilities.
Collaborative leader who builds strong relationships and fosters effective teamwork.
Strong analytical and holistic problem-solving skills, with the ability to set priorities and make sound decisions in a dynamic environment.
Continuous improvement mindset with a strong focus on lean simplification and operational excellence.
Solid understanding of project management principles and a business-oriented, solution-focused approach.
Excellent written and verbal communication skills in both Dutch and English.

Associate Director, Quality Control, Biochemistry, Biological Critical Reagents

Key skills