As a former Director of Corporate Compliance and Validation at Valeant Pharmaceuticals, Corinne was responsible for a diverse range of quality functions and systems. She led a number of teams tasked with various quality mandates related to: clinical release, analytical method validation, stability, technical transfer, inspection readiness and the complete scope of validation disciplines.
Some of her more notable projects have included leading a team responsible for establishing quality agreements and cGMP procedures with various suppliers to support clinical development. She established corporate validation policies and guidelines which were subsequently rolled out to the global network. Corinne was also the quality lead on several site to site technical transfer teams. As part of a corporate rationalization project Corinne led the transfer and shutdown of a QC laboratory and stability operation.
Using her strong microbiological background Corinne established corporate environmental monitoring standards for both production and development sites, helped to enhance site programs and frequently assisted with trouble shooting related issues.
Corinne has a wealth of experience dealing with regulatory inspections. She has provided corporate support at the site level during the preparation and execution of Pre-Approval and cGMP Inspections conducted by FDA, Canadian and European regulatory authorities.