Quality Assurance Manager

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

Job summary

An established industry player is seeking a Quality Assurance Manager to lead their department at a premier manufacturing site in Cramlington. In this pivotal role, you will ensure the highest standards of quality oversight across all QA activities, implementing effective Quality Management Systems. You will manage compliance assessments, coordinate product stability programs, and support manufacturing operations to maintain regulatory compliance. This role offers an exciting opportunity to influence quality processes and drive continuous improvement in a dynamic environment. If you are passionate about quality in the pharmaceutical sector and ready to lead a dedicated team, this position is perfect for you.

Qualifications

• Experience in the pharmaceutical industry is essential.
• Degree in Chemistry, Pharmacy, or related scientific discipline required.
• Team management experience in a GMP environment preferred.

Responsibilities

• Lead the Quality Assurance department ensuring compliance and quality oversight.
• Manage site programs for Quality Risk Management and Compliance Excellence.
• Coordinate routine and new product stability programmes.

Skills

Quality Assurance

Pharmaceutical Industry Experience

Team Management

Communication Skills

Continuous Improvement Tools

Attention to Detail

Education

Degree in Chemistry

Degree in Pharmacy

Degree in related scientific/statistical discipline

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.