Quality Assurance Manager

Job description

Job Description Secondary 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. You will manage and oversee site programmes for Quality Risk Management, Quality and Compliance Excellence, and support Permanent Inspection Readiness and Product Quality Reviews. You will also be responsible for the day-to-day leadership, development and performance of the QA team, ensuring priorities are effectively managed, resources are aligned to support site objectives, and departmental budgets are effectively managed. Role Responsibilities: Lead, coach and develop the QA team, providing day-to-day direction, prioritisation and support, while managing departmental resources and budget to ensure delivery of site quality objectives. Ensure Procedures, Policies, and Guidelines are reviewed and implemented. Coordinate routine, process change, and new product stability programmes. Lead the site’s Quality Plan and compliance assessment, communicating progress to senior management. 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: Degree in Chemistry, Pharmacy, or a related scientific discipline. Demonstrable experience within a pharmaceutical manufacturing environment. Proven leadership and people management experience within a GMP-regulated environment. Qualified Person (QP) eligible desirable but not essential. Strong communication, influencing, and stakeholder management skills. Demonstrated ability to lead and collaborate effectively across cross-functional teams. Ability to build and maintain strong working relationships across all levels of the organisation. Strong attention to detail, organisational skills, and a commitment to quality and compliance. Experience driving continuous improvement initiatives and leading interactions with regulatory authorities and external auditors. 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 10% Flexible Work Arrangements: Work Week Shift: Not Indicated Valid Driving License: Hazardous Material(s): Number of Openings: 1