Regulatory Affairs and Quality Assurance Manager

Overview: This leadership role is central to ensuring the site\’s Quality Management System remains compliant with GxP standards. You’ll act as the site lead for QMS and data integrity, supporting ongoing compliance across validation, documentation, and quality processes. The role sits within the Quality leadership team and plays a key part in building a strong compliance culture across the UK site and affiliate operations.

Key Responsibilities:
Lead QMS compliance activities across the site, focusing on continuous improvement and adherence to GxP
Act as the site’s data integrity subject matter expert, advising and educating teams on best practice
Maintain and develop the site’s validation master plan
Provide quality oversight on investigations, CAPAs, change controls, and audit readiness
Collaborate closely with QA, Manufacturing, Validation, and IT functions to ensure systems and processes meet regulatory expectations
Contribute to the Quality leadership team and support cross-functional quality initiatives

Ideal Experience:
Strong experience in pharmaceutical QA, with a focus on GMP/GDP
Background in validation and quality systems (e.g. change control, CAPA, audit prep)
Proven expertise in data integrity and compliance within a regulated environment
Confident communicator with solid stakeholder engagement skills
Familiarity with electronic quality systems (e.g. TrackWise, LIMS) is beneficial