Quality Assurance Manager

We are currently looking for an experienced Quality Assurance Manager.

Reporting to the Head of External Quality, in this role you will have specific responsibility for overall regulatory, customer inspection and audit management. The brief will focus on leading, managing and overseeing regulatory inspections, customer audits, managing, and supporting site leadership throughout the inspection/audit process to ensure optimal outcomes and a state of continuous inspection readiness.

Providing a focal point for all inspection and audit-related activity and for coordinating follow-up and responses to observations, a key priority will be to improve the efficiency with which these activities are managed. As well as reviewing current practices, you will be encouraged to collaborate with colleagues from across the network to incorporate their learnings. You will also need to build and maintain productive relationships with the Global Quality Assurance (GQA) team to enhance knowledge sharing and improve response times.

Key responsibilities:

• Manage regulatory inspections and customer audits.
• Advise, guide and support the site in the overall inspection management
• Manage site preparation for inspections and audits
• Organise and run the Back Room during audits
• Manage any outcomes/findings, ensure appropriate responses liaising with customers and Global Quality Assurance (GQA)
• Provide guidance for timely remediation and support response writing
• Work with QA and other departments to ensure that CAPA raised as a result of the above are SMART and that CAPAs are closed by the due dates.
• Responsible for leading the Site responses to the Global regulatory gap analysis
• Prepare and review regulatory inspection evidence files

What we need you to have:

• Bachelor’s degree (or equivalent) in a scientific or QA-related discipline
• Significant experience working within QA roles in GMP-regulated pharmaceutical – ideally biologics or biopharmaceutical – environments
• Significant experience managing regulatory (e.g., MHRA & US FDA, etc.) inspections.
• Experience working with drug substances
• Ability to meet strict deadlines.
• Ability to work in a team and solo capacity.
• Significant experience in risk management and project management.