Associate Director, Quality Control Biochemistry & Biological Critical Reagents

<p style="text-align:left">Job Description</p><p style="text-align:inherit"></p><p><b>Associate Director, Quality Control Biochemistry &amp; Biological Critical Reagents</b></p><p></p><p><b>Purpose of the role</b></p><p>The Associate Director is responsible for managing the Biological Critical Reagents (BCR) team. The BCR team manages the complete life cycle (acquisition, qualification, implementation, ongoing monitoring and stability) of Biological Critical Reagents. In addition, two Quality Control teams report on this role. He/she is responsible for the tactical planning and operational management of laboratory teams performing routine biochemical in‑process, release and stability testing, ensuring compliance with GMP and SHE requirements while driving continuous improvement and customer focus. The role oversees testing activities for environmental monitoring, biotechnological APIs, intermediates, and finished products, ensures the reliability of analytical methods and systems, and is accountable for timely regulatory submissions and on time delivery of qualified Biological Critical Reagents. In addition, the Associate Director develops and trains employees and actively embeds a “safety first, quality always” mindset across the organization.</p><p></p><p><b>Welcome to the team</b></p><p>The Associate Director QC B&amp;BCR reports to the Quality Control Microbiology &amp; Biochemistry Lead and provides leadership to the Biological Critical Reagents (BCR) team and multiple QC teams through two to three coaches (M1) and a team of specialists across various seniority levels.</p><p></p><p><b>Main responsibilities</b></p><ul><li>The Associate Director is responsible for managing 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.</li><li>The role provides clear operational oversight, communicates status and risks within IPT and CoE, and ensures the reliability of analytical methods and supporting systems, taking corrective or preventive action when required.</li><li>The position provides operational leadership to the Biological Critical Reagents (BCR) team and is accountable for the full lifecycle management of BCRs, including compliant testing, timely regulatory submission, and on time global delivery to Organon laboratories, contract laboratories, and regulatory agencies.</li><li>Responsibilities also include approval of BCR-related documentation, validation protocols and reports, change management, deviation handling, CAPA coordination, audit support, and strict adherence to approved methods and Quality Systems, while maintaining alignment with budget and profit plan targets.</li><li>In addition, the Associate Director manages workforce capacity and capability, ensuring the right staffing levels qualitatively and quantitatively, and supports recruitment, training, talent development, internships, and performance management in collaboration with HR.</li><li>The role oversees the laboratory project portfolio and leads strategic projects from assessment through delivery, ensuring scope, timelines, cost, and quality objectives are met.</li><li>A strong Safety, Health, and Environment (SHE) culture is actively promoted, and the Associate Director acts as deputy to the QC M&amp;B Lead, taking decision‑making and signatory responsibility during absences.</li></ul><p></p><p><b>Your profile</b></p><ul><li>Master’s or bachelor’s degree in Biochemistry, (Analytical) Chemistry, Biology, Pharmacy, or a related field.</li><li>Over 10 years of relevant experience, including people management, preferably within the pharmaceutical industry.</li><li>Strong expertise in pharmaceutical and biotechnological manufacturing, analytical chemistry, microbiology, GMP, validation, lean lab operations, SHE, and Quality Management.</li><li>Demonstrated ability to position Quality as a competitive advantage and to embed a strong quality culture across the Oss site.</li><li>Proven people leader with strong coaching, empowerment, and talent development capabilities.</li><li>Collaborative leader who builds strong relationships and fosters effective teamwork.</li><li>Strong analytical and holistic problem-solving skills, with the ability to set priorities and make sound decisions in a dynamic environment.</li><li>Continuous improvement mindset with a strong focus on lean simplification and operational excellence.</li><li>Solid understanding of project management principles and a business-oriented, solution-focused approach.</li><li>Excellent written and verbal communication skills in both Dutch and English.</li></ul><p style="text-align:inherit"></p><p style="text-align:left"><b>Secondary Job Description</b></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Who We Are: </b></p><p style="text-align:left"><span>Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions.  Our Vision is clear: A better and healthier every day for every woman.</span></p><p></p><p><span>As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants. </span></p><p></p><p></p><p style="text-align:inherit"></p><p style="text-align:left"><b><span>Search Firm Representatives Please Read Carefully </span></b><br />Organon LLC<span>, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. </span></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Annualized Salary Range</b></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Annualized Salary Range (Global)</b></p><p style="text-align:left"><b>Annualized Salary Range (Canada)</b></p><p style="text-align:left"><b>Please Note: Pay ranges are specific to local market and therefore vary from country to country.</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Employee Status: </b></p>Regular<p style="text-align:inherit"></p><p style="text-align:left"><b>Relocation:</b></p>No relocation<p style="text-align:inherit"></p><p style="text-align:left"><b>VISA Sponsorship:</b></p>No<p style="text-align:inherit"></p><p style="text-align:left"><b><span>Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites</span></b></p>No Travel Required<p style="text-align:inherit"></p><p style="text-align:left"><b>Flexible Work Arrangements:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Shift:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Valid Driving License:</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Hazardous Material(s):</b></p><p style="text-align:inherit"></p><p style="text-align:left"><b>Number of Openings: </b></p>1