Associate Director, GMP / GDP Compliance Purpose of the role Provide strategic compliance leadership to Organon and to Organon’s contract manufacturing operations (CMOs) involved in the manufacture and distribution of active pharmaceutical ingredients (API), biologics, finished pharmaceutical, and medical device products. Support global audits and health authority inspections, ensuring timely and effective implementation of corrective and preventive actions (CAPA) to maintain regulatory compliance. The position is located in Europe with remote work available. Partner with Organon and CMO management to identify, implement, and monitor CAPAs in response to audit and inspection findings; Serve as a subject matter expert on current good manufacturing practice (CGMP) and good distribution practice (GDP) requirements for pharmaceutical, biopharmaceutical, and medical device products. communicate insights to senior leadership. Author and review global standards and procedures to ensure alignment with evolving regulatory requirements. Minimum of 10 years in quality, operations, or technical roles within the pharmaceutical, biopharmaceutical, vaccine, or medical device industries. Proven ability to interpret and apply regulatory expectations to build and sustain a robust and compliant quality management system. Demonstrated leadership in navigating complex issues by integrating diverse viewpoints, making independent decisions, and advocating for evidence-based compliance positions with integrity. Familiarity with medical device standards and GMP requirements (e.G., Organon delivers ingenious health solutions that enable people to live their best lives. 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. A better and healthier every day for every woman. 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. Annualized Salary Range (Global) Please Note : Pay ranges are specific to local market and therefore vary from country to country. VISA Sponsorship : Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites Adaptable Work Arrangements : Shift :