Manage and oversee compliance activities for the Cell & Gene Therapy unit within GSK

•Manages and administrate the change management process (MaCC) and system for Biopharm R&D•Responsible for creating, analyzing, and reporting monthly change control key performance indicators and trends •Chair and manage weekly change control committee meetings •Implemented the electronic validated quality change management system (Trackwise) in Biopharm R&D CMC to replace the paper based change management system (Lotus Notes). •Responsible for organizing audit preparedness activities for internal and external inspections.•Key participant in internal & external inspections. •Delivers monthly trainings to business on change management and the use of the Controlled Document Management System (CDMS). •Coordinates the review/approval of SOP’s, analytical methods, equipment instructions, material specifications, master batch records, and other supporting documentation using CDMS (Controlled Document Management System)•Perform document editing to controlled documents to ensure completeness, accuracy, and compliance with GSK’s global quality policies, SOP’s and guidelines. •Partners with various key cross functional groups to develop, implement, and harmonize standard work practices via GMP, GLP, and GCP regulations. •Manages document archival and retention