Associate Director - Quality Management System Operational

Job Description Interested candidates are requested to contact only the hiring manager or the recruiter for any initial information. The Position The Quality Management System (QMS) Associate Director reports to the QMS Director, overseeing Quality Management System (QMS) topics within the Quality Compliance Organization as part of Organon Manufacturing & Supply (OMS). This position is crucial in Organon’s effort to create a simplified, integrated, user-centric global Quality Management System for our products. The objective is to ensure consistently compliant product quality, continuous improvement, and effective life-cycle management. Additionally, the role is key to ensuring the QMS is always inspection-ready concerning Organon’s Medical Devices. Aligned with the Quality Compliance organization and key stakeholders, this role develops and maintains QMS topics. Responsibilities Ensuring the end-to-end life cycle process for the QMS is well-defined according to quality system attributes, with a robust management system in place to monitor the process and address any gaps. Confirming processes are defined with adequate procedures, governance, and clear roles, responsibilities, and accountabilities. Defining and supporting the installation of the organization and infrastructure needed to execute QMS processes. Developing and maintaining metrics for ongoing evaluation to ensure the system functions as intended, is reviewed by appropriate management levels, and serves as a basis for continual improvement. Developing, maintaining, and continually improving the permanent inspection process for Medical Device inspections. Collaborating across groups, functions, and divisions (OMS and Organon Research and Development) to lead permanent inspection readiness activities, including executing gap assessments, tracking aligned gaps to resolution, and escalating risks to senior management. Maintaining a robust inspection process that maximizes inspection success and minimizes non-conformances resulting from inspection findings. Under the direction of their manager, ensures the Medical Device inspection readiness process is upheld. Design, deploy, and maintain QMS topics. Gather input for the design, development, and implementation of the OMS QMS deployment strategy. Lead cross-functional global teams in developing topics within OMS and interface with other chapters, topics, and stakeholders across the network as needed. Collaborate with topic owners and subject matter experts to assess system performance and drive continuous improvement. Ensure quality requirements are sound and compliant by leveraging insights, experience, and judgment to proactively enhance the company’s QMS. Provide leadership and technical direction on regulatory requirements within the GMP/GDP environment. Monitor global regulations impacting assigned topics to develop and maintain accurate interpretations of regulatory requirements per market, in alignment with QMS policies and procedures. Identify, resolve, mitigate, or appropriately escalate any issues or delays in content development project execution, ensuring all targets are met on time, in full, and to quality standards. Drive the development, implementation, and realization of permanent inspection readiness for assigned topics. Conduct gap assessments to support Medical Device inspections by collaborating with subject matter experts, documenting findings, and tracking agreed-upon gaps to resolution. Prepare inspection front room, back room, and subject matter experts for executing inspections related to Medical Devices. Maintain tools to track progress for permanent inspection readiness and regularly communicate status to senior management. Communicate the status and outcomes of Medical Device inspections to senior leaders. Track and ensure follow-up actions resulting from Medical Device inspections are satisfactorily completed. Required Education, Experience and Skills Degree in Life Sciences, Engineering, or a related relevant discipline. Minimum of 8 years of experience in the FDA and/or EU regulated pharmaceutical environment, preferably in a manufacturing site leading manufacturing and/or quality roles, or in Global Quality. Experience in pharmaceuticals, biologics, devices, and API regulations is preferred. Demonstrated leadership in Quality & Compliance, with in-depth knowledge of global health authority regulations and requirements, and the ability to effectively translate and communicate these requirements. Subject matter expertise in regulatory requirements and expectations for Medical Devices, clinical supply, commercialization, and/or validation topics. Strong collaboration and cross-functional leadership skills to drive continuous improvement, promote knowledge sharing, and endorse best practices across sites and functions. Excellent facilitation and project management skills, with strong verbal and written communication abilities. Proven ability to lead and implement multiple projects/tasks simultaneously, managing competing and/or changing priorities effectively. Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives. Proven ability to make and act on decisions while balancing speed, quality, and risk. Ability to provide innovative ideas to improve quality and compliance, including seeking new information and external insights. Capable of working and communicating effectively with all levels of the organization globally. Proven ability to effectively initiate and drive change across a diverse and multi-functional organization. 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 At Organon, we aspire to improve the lives of people globally by unleashing the promise of trusted brands across women’s health and other important therapeutic areas. We are committed to becoming the world’s leading women’s health company investing in innovations that support women’s wellbeing. Fueled by its leading contraceptives and fertility businesses, Organon will invest in innovations that support the distinct health care needs of women today. Organon will also focus on its important biosimilars business, focusing on oncology and inflammatory diseases, while also maximizing the value of its trusted dermatology, pain, respiratory and cardiovascular portfolio in countries around the world where there is still great need for these treatments.