Manage the design, implementation and rollout of Quality Management System (Veeva Quality Vault) and Learning Management System (LearnaboutGMP) utilizing cross-functional resources. Develop and manage the regulatory inspection process, to include back room and front room communications, SME assignments, and mobilization planning. Support inspection readiness activities throughout the organization. Provided company-wide training for inspection readiness, GxP Quality Systems, Veeva QMS

Manage and support projects for continuous improvement or implementation of Vertex Quality Management System elements, to include Quality Management Review and conducting research and translation of applicable regulations into development and approval of Quality policies: Business Continuity, Materials Management, Product Recalls/Returns, Study Execution, Laboratory Controls, Facilities & Equipment. Facilitate continuous improvement projects, related to Events/CAPA, Vendor and Audit Mgmt

Managing Quality professionals supporting the successful completion of Third Party Verification events in prep/staging room environment; controlling all evidence and documentation submitted to substantiate completion of CD work plan, including archival and retrievals. Developed and trained CDMO teams on process for verification, which is similar to inspection preparedness.

Manage Quality Systems, including Document Control, CAPA, Deviations, Complaints and Change Control, in conjunction CMOs and vendors, and serve as Administrator for MasterControl (EDMS); conduct internal audits and manage regulatory agency inspections.