Paige E. Kane PhD, CPIP

Paige Kane PhD, CPIP, Is the Associate Vice President of Operational Readiness/Excellence at CAI. She is an industry leader with over 30 years’ experience across the pharmaceutical Lifecyle from R&D through manufacturing at MSD, Pfizer, Genetics Institute, Wyeth, and Monsanto. In addition to her 15 years in the field of Knowledge Management, Operational Excellence, and Global Strategy development, she has led Quality Systems Groups focusing on Automation Compliance, Data Integrity, Computer Validation, and Change Control during startup and operations for biologics facilities in the US and Ireland. Dr. Kane has been a ISPE member for over 20 years, frequently contributing to ISPE GPG teams including the Pharm 4.0 Baseline Guide, the Knowledge Management guide and multiple GAMP guides. She previously led the ISPE Global Biotech CoP and Americas/EU GAMP regional CoPs. Kane holds a PhD in Pharmaceutical and Regulatory Science from Technical University Dublin (Dublin, Ireland). She is frequent industry author and presenter and continues her research as a member of the TU Dublin Pharmaceutical Regulatory Sciences Team (PRST).