Quality Assurance Manager

bioM?rieux BV; Cramlington; On-site; GBP 40,000 - 60,000

Job description

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.