Commercially minded leader driving revenue and customer growth for a global SaaS company. Focus on operational excellence and team development across the region.
SI
Onsite Associate Director, Quality Control, Biochemistry, Biological Critical Reagents
Posted 5 hours ago
About the role
- Associate Director managing the Biological Critical Reagents team in Quality Control for a pharmaceutical company. Driving tactical planning and operational management for biochemical testing while ensuring compliance with GMP and safety regulations.
Responsibilities
- 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.
Requirements
- 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.
Benefits
- N/A
Job title
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Degree requirement
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