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- Tasks: Lead compliance efforts in pharmaceutical manufacturing and distribution, ensuring regulatory standards are met.
- Company: Join Organon, a $6.5 billion global healthcare company focused on women's health and community well-being.
- Benefits: Enjoy flexible work arrangements and the opportunity to make a real impact in healthcare.
- Why this job: Be part of a mission-driven team dedicated to improving lives and shaping the future of health solutions.
- Qualifications: 10+ years in quality or operations roles; expertise in GMP/GDP regulations required.
- Other info: Remote work available; travel up to 10% may be required.
The predicted salary is between 48000 - 72000 ÂŁ per year.
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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
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Associate Director, GMP/GDP Compliance employer: Organon
Contact Detail:
Organon Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Director, GMP/GDP Compliance
✨Tip Number 1
Network with professionals in the pharmaceutical and biopharmaceutical industries. Attend industry conferences or webinars where you can meet people who work at Organon or similar companies. Building these connections can provide valuable insights and potentially lead to referrals.
✨Tip Number 2
Stay updated on the latest GMP/GDP regulations and compliance trends. Subscribe to relevant journals or follow regulatory bodies on social media. This knowledge will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Prepare for potential interview questions by reviewing common scenarios related to CAPA implementation and audit readiness. Think of specific examples from your past experience that showcase your leadership and problem-solving skills in compliance.
✨Tip Number 4
Engage with Organon’s online presence. Follow their social media accounts and participate in discussions. Showing genuine interest in the company and its mission can set you apart from other candidates during the selection process.
We think you need these skills to ace Associate Director, GMP/GDP Compliance
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and qualifications required for the Associate Director, GMP/GDP Compliance position. Tailor your application to highlight relevant experience in compliance leadership and regulatory knowledge.
Highlight Relevant Experience: In your CV and cover letter, emphasise your 10+ years of experience in quality, operations, or technical roles within the pharmaceutical industry. Be specific about your expertise in GMP/GDP regulations and any direct experience with audits or inspections.
Showcase Leadership Skills: Demonstrate your leadership abilities by providing examples of how you've navigated complex compliance issues, integrated diverse viewpoints, and driven consensus among teams. This is crucial for a role that requires strategic compliance leadership.
Tailor Your Application: Customise your application materials to reflect Organon's values and mission. Mention your commitment to women's health and how your background aligns with their vision of delivering ingenious health solutions.
How to prepare for a job interview at Organon
✨Showcase Your Regulatory Knowledge
Make sure to highlight your expert-level knowledge of GMP/GDP regulations during the interview. Be prepared to discuss specific examples of how you've applied these regulations in past roles, especially in relation to international regulatory authorities like the FDA and EMA.
✨Demonstrate Leadership Skills
This role requires strong leadership abilities. Share experiences where you've navigated complex compliance issues, integrated diverse viewpoints, and made independent decisions. Emphasise your ability to foster alignment across teams to achieve common objectives.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving skills in real-world situations. Think about past audits or inspections you've been involved in and how you handled challenges, particularly regarding CAPA implementation and inspection readiness.
✨Stay Updated on Industry Trends
Being active in industry organisations is a plus. Discuss any recent trends or changes in regulatory requirements you've encountered and how they might impact compliance strategies. This shows your commitment to staying informed and proactive in your field.
