PAssociate Director, GMP / GDP Compliance /ppbPurpose of the role /b /ppProvide 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. /ppThe position is located in Europe with remote work available. /ppbMain responsibilities /b /pulliPartner with Organon and CMO management to identify, implement, and monitor CAPAs in response to audit and inspection findings; independently verify CAPA effectiveness and closure. /liliSupport inspection readiness across Organon sites and functions; participate in audits and inspections to ensure successful outcomes. /liliDraft and review health authority correspondence, ensuring clarity, accuracy, and alignment with regulatory expectations. /liliServe as a subject matter expert on current good manufacturing practice (CGMP) and good distribution practice (GDP) requirements for pharmaceutical, biopharmaceutical, and medical device products. /liliGather and analyze internal audit findings and external regulatory intelligence to identify new and emerging trends; communicate insights to senior leadership. /liliAuthor and review global standards and procedures to ensure alignment with evolving regulatory requirements. /liliActively participate in industry organizations (e.g., PDA, ISPE, BioPhorum) to stay current on regulatory trends and to benchmark inspection approaches. /li /ulpbRequired qualifications /b /pulliMinimum of 10 years in quality, operations, or technical roles within the pharmaceutical, biopharmaceutical, vaccine, or medical device industries. /liliDemonstrated expert-level knowledge of pharmaceutical GMP / GDP regulations across multiple international regulatory authorities (e.g., FDA, EMA, MHRA). /liliProven ability to interpret and apply regulatory expectations to build and sustain a robust and compliant quality management system. /liliDemonstrated leadership in navigating complex issues by integrating diverse viewpoints, making independent decisions, and advocating for evidence-based compliance positions with integrity. /liliExperienced in fostering alignment across teams with varied perspectives to drive consensus and achieve common objectives, with a strong sense of accountability and escalation when needed. /liliWilling and able to travel up to 10% of the time. /li /ulpbHighly desired qualifications /b /pulliMinimum of 5 years of direct experience of GMP audits or inspections, either from working for a health authority or managing health authority inspections. /liliStrong technical and regulatory knowledge in aseptic manufacturing, preferably with hands-on experience. /liliFamiliarity with medical device standards and GMP requirements (e.g., ISO 13485, EU MDR). /li /ulpSecondary Job Description /ppbWho We Are : /b /ppOrganon 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. /ppAs 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. /ppbSearch Firm Representatives Please Read Carefully /b /ppOrganon LLC, 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. /ppAnnualized Salary Range /ppAnnualized Salary Range (Global) /ppbAnnualized Salary Range (Canada) /b /ppuPlease Note : /u Pay ranges are specific to local market and therefore vary from country to country. /ppuEmployee Status : /u Regular /ppuRelocation : /u No relocation /ppbVISA Sponsorship : /b /ppuTravel Requirements : /u Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites /ppFlexible Work Arrangements : /ppShift : /ppValid Driving License : /ppNumber of Openings : /ppuRequisition ID : /u R533177 /ppJ-18808-Ljbffr /ppJ-18808-Ljbffr /p #J-18808-Ljbffr