Associate Vice President Technical Excellence & Transformation
Paige Kane PhD, CPIP, Is the Associate Vice President of Technical Excellence & Transformation 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).
The complex transformation toward Pharma 4.0™ requires comprehensive skill management. This case study builds on a previously presented framework and follows the fictional company NewCo as it tackles the challenge of developing a future-ready workforce during a plant expansion project. Guided by the framework, NewCo first establishes skill management governance and a cross-functional team. It...
The pharmaceutical sector is undergoing a profound transformation. As digital technologies continue to evolve, organizations are under increasing pressure to modernize legacy systems, enhance operational efficiency, and maintain compliance in a rapidly shifting regulatory landscape. The Digital Transformation track at the
In the March/April issue of Pharmaceutical Engineering, we dive into "The Workforce of the Future," highlighting a future-ready workforce, employee well-being, and a collaborative work environment in an industry dealing with a skills gap. Learn more about these and other issues in the current issue of the magazine.
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation and evolution is mergers and acquisitions (M&A). M&A can enable academic researchers and small companies to fund and commercialize innovative products. In addition, M&A can help larger organizations secure new and complementary technology and products. In the pharmaceutical...
Although data and knowledge are both stand-alone disciplines that need to be systematically managed, they also must have a connection. Understanding the relationship between data and knowledge management processes and how people are leveraging advances like Pharma 4.0™ combined with these processes enables quality data transition to knowledge that can help pharmaceutical companies. The authors...