Simplify

Associate Director, Quality Control, Biochemistry, Biological Critical Reagents

Simplify

full-time

Posted on:

Location Type: Office

Location: Oss • Netherlands

Visit company website

Explore more

✨ AI Apply
Apply

Job Level

Senior

About the role

  • 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 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
biochemical testinganalytical methodsGMPvalidationmicrobiologylean lab operationsQuality Managementproject managementregulatory submissionsCAPA
Soft Skills
people managementcoachingempowermenttalent developmentcollaborationteamworkanalytical problem-solvingdecision-makingcontinuous improvementcommunication