Organon - Associate Director, Change Control Center of Excellence (COE)

Job Description

The Quality Management Systems (QMS) Associate Director reports to the QMS Director overseeing the Change Control Center of Excellence (COE) within the Quality Compliance Organization as part of Organon Manufacturing & Supply (OMS).

Critical to the success of this role is, in alignment with the Quality Compliance organization and key stakeholders is to assist with the execution of the strategy for development and deployment of the OMS Quality Management System as Organon stands up as an independent entity to ensure robust compliance is maintained, while also acting as an enabler for the current and future operations of Organon.

This position is key in Organon's effort to create a simplified, integrated, user-centric global Quality Management System (QMS) for our products, with an objective to enable consistently compliant product quality, continuous improvement, and effective life-cycle management. The position, in alignment with the OMS Quality Compliance team and key stakeholders, will help define the strategy for development and deployment of the OMS Quality Management System as Organon stands up as an independent entity to ensure robust compliance is maintained, while also acting as an enabler for the current and future operations of Organon.

The QMS Associate Director is responsible for the maintenance and support of the Organon change control process as well as the development of processes, procedures, and corresponding controlled documentation and systems assigned within the scope of the QMS Change Control topic.

The QMS Associate Director is also responsible for ensuring the end-to-end life cycle process for the QMS is well defined per the attributes of a quality system, there is a robust management system in place to monitor the process and that any gaps are identified and managed to completion.
  • Processes are defined with adequate Procedures, Governance, and clear Roles, Responsibilities, and Accountabilities
  • The Organization and Infrastructure to support the execution of the processes are defined and installed
  • Metrics are developed for the ongoing evaluation that the system is working as intended, reviewed by the appropriate levels of management, and used as a basis for continual improvement

Primary activities include, but are not limited to:

Responsible for supporting internal and external OMS execute compliant change control processes. Obtain input into the design and development as well as the implementation of the OMS QMS deployment strategy related to Change Control. Lead cross-functional global teams developing change control processes and interface with other chapters/topics, and stakeholders across the network as needed. Work with (sub-) topic owners and subject matter experts to assess system performance and drive continual improvement. Ensure quality requirements are sound and compliant by using insights, experience, and judgment to proactively drive and improve the company's QMS Provide leadership and technical direction on regulatory requirements for the above in the GMP/GDP environment. Monitor global regulations with impact on assigned topics to develop and sustain accurate interpretation of regulatory requirements per market, in alignment with QMS policies and procedures. Help identify, resolve/mitigate or appropriately escalate any issues or delays in content development project execution, and ensure all targets are met on time, in full, and to quality. Drive the development, implementation, and realization of permanent inspection readiness for assigned topics.

Minimum Education and Experience:
  • BS in Life Sciences, Engineering or related relevant discipline.
  • At least 8 years in the FDA and/or EU regulated pharmaceutical environment; preferably in a manufacturing site in leading manufacturing and/or quality roles and/or in Global Quality; experience in vaccines, biologics, devices and API regulations preferred.
  • Demonstrated leadership in Quality & Compliance discipline and in-depth knowledge of global health authority regulations and requirements, with the ability to effectively translate and communicate these requirements.
  • Subject matter expertise in regulatory requirements and expectations for change control.
  • Strong collaboration and cross-functional leadership skills to drive continuous improvement and promote knowledge sharing and endorsement of best practices across sites & functions.
  • Excellent facilitation and project management skills, with strong verbal and written communication skills.
  • Proven ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.
  • Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
  • Ability to provide innovative ideas to improve quality and compliance that create value 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


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.

At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.

At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.


In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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.

Employee Status:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Remote Work, Telecommuting

1st - Day

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R110616