Quality Assurance System Manager

Job DescriptionOverview:This role is central to ensuring the site's Quality Management System remains compliant with GxP standards. Youll 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 GxPAct as the sites data integrity subject matter expert, advising and educating teams on best practiceMaintain and develop the sites validation master planProvide quality oversight on investigations, CAPAs, change controls, and audit readinessCollaborate closely with QA, Manufacturing, Validation, and IT functions to ensure systems and processes meet regulatory expectationsContribute to the Quality leadership team and support cross-functional quality initiativesIdeal Experience:Strong experience in pharmaceutical QA, with a focus on GMP/GDPBackground in validation and quality systems (e.g. change control, CAPA, audit prep)Proven expertise in data integrity and compliance within a regulated environmentConfident communicator with solid stakeholder engagement skillsFamiliarity with electronic quality systems (e.g. TrackWise, LIMS) is beneficial

Created: 2025-06-27