Associate Director, External Manufacturing Quality Assurance
Job Description
Permanent contract is possible
Secondary Job Description
We are seeking a highly skilled and experienced Associate Director of External Manufacturing Quality Assurance to join our Global Quality Operations team. In this leadership role, you will provide strategic quality oversight and technical support to external manufacturing partners, ensuring compliance with global GMP standards and regulatory requirements. Your decisions will directly impact product quality, patient safety, and regulatory success.
A Day in the Life – What You’ll Do:
- Provide quality oversight to external manufacturing partners, ensuring compliance with company policies and global GMP/regulatory requirements.
- Offer technical QA/QC support, including product testing, batch documentation review, and deviation investigations.
- Manage product release processes, ensuring conformance to specifications and regulatory standards.
- Support new product introductions with compliance input and inspection readiness.
- Lead or support significant investigations and product recalls.
- Act as a regulatory liaison with authorities regarding external partner activities.
Your Impact – How You’ll Make a Difference:
- Ensure quality and compliance across all external manufacturing activities.
- Lead continuous improvement initiatives to enhance quality systems and partner performance.
- Support regulatory excellence through transparent, compliant interactions with authorities.
- Enable innovation by supporting the successful launch of new products.
- Foster global collaboration across cross-functional teams and external partners.
- Champion a culture of quality, safety, and operational excellence.
Qualifications:
About You – What You Bring:
- Bachelor’s or master’s degree in science, Engineering, or a related technical field (e.g., Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering).
- Prior experience in the pharmaceutical industry is required; experience in API manufacturing or external manufacturing support is preferred.
- Strong knowledge of Quality Systems, Quality Assurance, and Quality Control, with a solid understanding of global GMP standards and regulatory compliance.
- Broad operational expertise in manufacturing, supplier management, and supply chain processes.
- Demonstrated ability to make sound decisions in complex or rapidly changing environments.
- Familiarity with FDA, ICH, and other global regulatory frameworks.
What We Offer:
- Competitive salary and 3% year-end bonus
- 35.5 days of paid time off
- Comprehensive health care coverage
- Solid pension and incentive plans
- Commuting allowance
- Parental leave for all parents
- Access to training, coaching, and development programs
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:
No
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
25%
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID: R534462