Associate Director, Gmp / Gdp Compliance

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.

Main responsibilities

• Partner with Organon and CMO management to identify, implement, and monitor CAPAs in response to audit and inspection findings; independently verify CAPA effectiveness and closure.
• Support inspection readiness across Organon sites and functions; participate in audits and inspections to ensure successful outcomes.
• Draft and review health authority correspondence, ensuring clarity, accuracy, and alignment with regulatory expectations.
• 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.
• Gather and analyze internal audit findings and external regulatory intelligence to identify new and emerging trends; communicate insights to senior leadership.
• Author and review global standards and procedures to ensure alignment with evolving regulatory requirements.
• Actively participate in industry organizations (e.g., PDA, ISPE, BioPhorum) to stay current on regulatory trends and to benchmark inspection approaches.

Required qualifications

Highly desired qualifications

Secondary 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.

As 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.

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.

Annualized Salary Range

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 : No 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 :

Number of Openings :

Requisition ID : R

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