Kathleen Waters Genentech, Inc.

Ms. Waters leads the Global Quality Systems Biologics Validation and Operation group, responsible for defining the Quality Management Systems strategy for manufacturing systems and utility systems qualification, process development, cleaning and process validation, process monitoring and trending and systems maintenance. In addition, she is currently co-leading the development of the Product and Process Knowledge Management program. Kate has been at Genentech for over 22 years, having held positions in Engineering, Operations and Quality. Kate frequently champions strategic initiatives and programs, leading or collaborating on global initiatives, driving cross-functional engagement, and leveraging industry best practices. Along with PDA, Kate is a member of the Society of Women Engineers (SWE), International Society of Automation (ISA), International Society of Pharmaceutical Engineering (ISPE) and PAR (Process Automation Roundtable).