• Develops the strategy for, and directs the overall management of the Clinical QC, Controlled Document/Training, and Continuous Improvement teams within Global Quality Compliance. • Responsible for the strategy to ensure that all phases of Regulatory Health Authority inspections are managed and executed consistently, professionally and proactively. • Identifying and analyzing changes to GCP regulations globally and assessing complaints to determine GCP compliance status. • Reporting to the Vice President, Global Quality Compliance. • Works with the Continuous Improvement Administrator and related CAPA Analysts to develop effective working practices for the execution and administration of a corporate continuous improvement program. • Ensures the effective execution of the Clinical QC team including the establishment of standards for reviews of TLFs, CSRs, etc. for submission readiness. • Responsible for managing employee training files and related documentation for the UBC organization including the establishment of role based training matrices. • Lead a team that supports regulatory inspections related to both UBC's overall GCP/GVP compliance across all service areas as well as supporting the regulatory inspections of clients.