Job Description The Position: This high-level, individual contributor role will be part of the Medical Device and Combination Product Quality team. Reporting to the Director of HPQA, the Associate Director will participate in and/or lead various initiatives to support Quality plans and objectives, building QMS capabilities that impact every aspect of our business processes, systems, and data. The Associate Director will collaborate with cross-functional teams to identify opportunities for improvement and resolution, balancing effective operations with transformative initiatives. Responsibilities include developing, documenting, and maintaining technical business solutions, as well as auditing data, information, procedures, and systems to ensure compliance with current Good Manufacturing Practices (cGMPs), other worldwide regulations, and Organon requirements. Responsibilities: Understands evolving global regulatory regulations and works proactively to ensure HPQA remains compliant. Supports the maintenance, knowledge transfer, and development of Organon-specific device systems as needed. Participates in Organon teams addressing cGMP and quality issues related to pure Medical Devices and the device constituent part of a Combination Product. Manages activities within electronic systems such as TrackWise, SAP, Success Factors (LMS), etc. Supports the development and implementation of Quality metrics, Quality Standards, and Global/Above Site Procedures as needed. Provides training and coaching to initiate quality improvements within Development, Operations, and Quality departments as needed. Supports sites with new or revised QMS QM Quality Standards and/or Global Procedures. Provides input to design and manufacturing documentation, including DHF, DRMF, Dossiers, material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure products can be registered, manufactured, and distributed. Facilitates the translation of customer needs into critical quality and design input/output requirements, including but not limited to chemical, physical, or performance specifications. Required Education, Experience and Skills Preferred experience in assessing US FDA 21 CFR Part 4 and Part 820, EU MDR:2017/745, and ISO 13485:2016 for reviewing Quality Management System documents for Organon's Quality Manual. Strong knowledge of applicable regulations and the ability to work in a team environment to identify gaps in QMS documents. Working knowledge of the design, manufacture, packaging, testing, release, storage, and distribution of medical devices and/or medical device combination products. Ability to build relationships within a team environment. Experience using IT systems for Quality Management. Working knowledge of regulatory expectations for the design, manufacture, packaging, and distribution of medical devices or medical device combination products, with experience in quality assurance or regulatory oversight of these products. Experience authoring, reviewing, and approving Quality Management System documents. Solid organizational skills, including attention to detail and multi-tasking abilities. Effective interpersonal skills and the ability to work collaboratively across diverse teams and networks, fostering cooperation in others. Effective written and oral communication skills, with the ability to speak up and contribute to team discussions. Preferred experience and skills: Remediation experience is desired. Experience with Device Quality Management Systems is desirable Knowledge of current GMPs for combination products. Strong understanding of Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and project management principles is desirable. Education/Experience minimum requirement: A bachelor’s degree in (Science or Engineering or associated fields) with a minimum of 7 years related experience OR Master’s degree (Science or Engineering or associated fields) and 5 years related experience OR Ph.D. (Science or Engineering or associated fields) and 3 years of related experience. Advanced degrees may be used to reduce required experience if necessary leadership skills can be demonstrated. Secondary Language(s) Job Description Who We Are: 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. US and PR Residents Only For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement OFCCP Pay Transparency Rule Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law. Search Firm Representatives Please Read Carefully Organon 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. Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Annualized Salary Range (US) Annualized Salary Range (Global) Annualized Salary Range (Canada) Please Note: Pay ranges are specific to local market and therefore vary from country to country. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites. Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 1