Quality Assurance Manager in UK

Northreach is a dynamic recruitment agency that connects businesses with top talent in the Advanced therapy, fintech, and digital sectors.

Our mission is to provide a seamless and personalised recruitment experience for clients and candidates, and to create a positive work environment that encourages equality, innovation, and professional growth.

Job Summary:

As the Senior Manager, Site Quality Assurance, you will play a pivotal role in overseeing and enhancing quality assurance operations at our manufacturing site.

Reporting to the Site Leadership Team (SLT), you will lead a team of QA professionals, ensuring compliance with regulatory standards and fostering a culture of continuous improvement.

Key Responsibilities:

• Manage all site-related QA operations in accordance with Quality Agreements and GMP guidelines.
• Serve as the QA representative on the Site Leadership Team.
• Lead adherence to local or corporate Quality Management Systems (QMS).
• Collaborate in developing the Quell PQS, including implementing an eQMS where applicable.
• Define and develop new quality processes, policies, and data management systems.
• Establish and monitor quality standards and metrics to ensure compliance and effectiveness.
• Utilize quality metrics to mitigate risks, enhance compliance, and improve business processes.
• Identify and communicate significant quality-related matters or risks affecting product quality and regulatory compliance.
• Oversee complex QA activities related to manufacturing, testing, and clinical trials, ensuring compliance with regulatory requirements.
• Manage elements of the PQS pertaining to cellular therapies manufacture, including document control, risk management, training, and audits.
• Develop, review, and approve Quality and GxP-related documentation.
• Lead risk assessments and investigations as required.
• Approve equipment, materials, and services for site use.
• Conduct external audits as necessary.
• Provide strategic input into decisions impacting the Quality Assurance department.
• Deliver QA-related training and basic GMP training as needed.
• Act as a subject matter expert on Quality-related processes.
• Lead or represent QA in related projects, identifying metrics, issues, and mitigation strategies.
• Foster a quality culture of continuous improvement within the team and across the Site Leadership Team.
• Ensure inspection readiness and support regulatory agency inspections.
• Recruit, lead, motivate, and develop a team of QA professionals.
• Support quality-related activities across sites as required.

Minimum Qualifications and Experience:

• Minimum 10 years' experience in GMP manufacturing, with a focus on QA/Quality roles.
• Experience in QA support for ATMP manufacture preferred.
• Demonstrated leadership of small QA teams.
• Proficient in providing scientifically sound, risk-based quality advice.
• Extensive experience in writing and reviewing GxP documents.
• Strong knowledge of GMP principles, sterile production, and regulatory requirements for cell therapy products.
• Experience in generating and utilizing quality metrics.

Educational Requirements:

• University degree in a biological science, chemistry, or equivalent field.
• IRCA Associate Auditor certification desired.