Quality Assurance Manager

Job Description

Organon is hiring a Quality Assurance Manager to join our world class manufacturing site in Cramlington, Northumberland. In this role, you will lead the Quality Assurance department at the site, ensuring quality oversight for all QA activities. This position provides leadership and direction for implementing Quality Management Systems. Responsibilities include managing and overseeing site programs for Quality Risk Management, Quality and Compliance Excellence, and supporting Permanent Inspection Readiness and Product Quality Reviews.

Role Responsibilities:

• Lead the site’s Quality Plan and compliance assessment, communicating progress to senior management.
• Ensure Procedures, Policies, and Guidelines are reviewed and implemented.
• Coordinate routine, process change, and new product stability programmes.
• Lead the site’s QMS project and Quality Council meetings.
• Develop and manage Annual Product and Equipment Reviews.
• Manage Laboratory support systems and supplier management programmes.
• Oversee Lifecycle Documents, Records Management, and site training.
• Support QA function for Manufacturing Operations and ensure compliance with regulations.

Qualifications, Skills & Experience:

• Experience in the pharmaceutical industry.
• Degree in Chemistry, Pharmacy, or related scientific/statistical discipline.
• Team management experience in a GMP environment.
• Ideally qualified to act as a Qualified Person (desired but not essential).
• Strong communication skills and ability to lead cross-functional teams.
• Ability to build good working relationships with other functional groups.
• Attention to detail and well-organised.
• Experience with Continuous Improvement tools and communicating with external auditors.

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:

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:

Hazardous Material(s):

Number of Openings: