Join to apply for the Associate Director, GMP/GDP Compliance role at Organon
1 week ago Be among the first 25 applicants
Join to apply for the Associate Director, GMP/GDP Compliance role at Organon
Get AI-powered advice on this job and more exclusive features.
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.
Job Description
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
* Minimum of 10 years in quality, operations, or technical roles within the pharmaceutical, biopharmaceutical, vaccine, or medical device industries.
* Demonstrated expert-level knowledge of pharmaceutical GMP/GDP regulations across multiple international regulatory authorities (e.g., FDA, EMA, MHRA).
* Proven ability to interpret and apply regulatory expectations to build and sustain a robust and compliant quality management system.
* Demonstrated leadership in navigating complex issues by integrating diverse viewpoints, making independent decisions, and advocating for evidence-based compliance positions with integrity.
* Experienced 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.
* Willing and able to travel up to 10% of the time.
Highly Desired Qualifications
* Minimum of 5 years of direct experience of GMP audits or inspections, either from working for a health authority or managing health authority inspections.
* Strong technical and regulatory knowledge in aseptic manufacturing, preferably with hands-on experience.
* Familiarity with medical device standards and GMP requirements (e.g., ISO 13485, EU MDR).
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
Shift
Flexible Work Arrangements:
Valid Driving License
Hazardous Material(s):
Number Of Openings
1
Requisition ID:R533177
Seniority level
* Seniority level
Director
Employment type
* Employment type
Full-time
Job function
* Job function
Other
* Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Organon by 2x
Sign in to set job alerts for “Associate” roles.
London, England, United Kingdom 1 week ago
London, England, United Kingdom 2 weeks ago
London, England, United Kingdom 2 days ago
London, England, United Kingdom 1 week ago
Sales Associate - New Bond Street (Fixed Term)
London, England, United Kingdom 2 days ago
London, England, United Kingdom 4 weeks ago
London, England, United Kingdom 1 week ago
Amazon Fresh Retail Associate - London, Amazon Fresh
London, England, United Kingdom 1 day ago
2025 Graduate Analyst – Investment Banking, Technology, Media & Telecom (TMT)
London, England, United Kingdom 2 weeks ago
City Of London, England, United Kingdom 18 hours ago
Operations Associate (Part-Time) - Covent Garden
London, England, United Kingdom 2 weeks ago
Sales Associate - Selfridges (temporary 6 months)
Greater London, England, United Kingdom 2 weeks ago
London, England, United Kingdom 5 days ago
London, England, United Kingdom 3 weeks ago
London, England, United Kingdom 1 week ago
Sales Associate - London New Bond Street
London, England, United Kingdom 2 days ago
Business Operations | Analyst/Associate | London
London, England, United Kingdom 1 week ago
London, England, United Kingdom 1 week ago
Operations Associate (Full-Time) - Regent Street
London, England, United Kingdom 3 days ago
Team Member - 120 Oxford Street (N93598)
London, England, United Kingdom 2 weeks ago
London, England, United Kingdom 1 day ago
Jumeirah Lowndes - Front Office - Night Porter
London, England, United Kingdom 1 week ago
Team Member - 120 Oxford Street (N93600)
London, England, United Kingdom 2 weeks ago
London, England, United Kingdom 2 weeks ago
London, England, United Kingdom 1 day ago
London, England, United Kingdom 1 week ago
Front Desk Agent - Front Office - Jumeirah Lowndes
Kensington And Chelsea, England, United Kingdom 1 week ago
London, England, United Kingdom 2 weeks ago
London, England, United Kingdom 1 month ago
Greater London, England, United Kingdom 1 week ago
Wembley, England, United Kingdom 2 days ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr