Kathleen Silva is the Head of Quality Management Systems and Audits. In this role she is responsible for overseeing the global Life Science framework for compliance with Quality, Regulatory and Industry standards. This is accomplished through regular internal audits of our Life Science sites along with global Life Science Standards and Procedures.
Previously, Kate held the role of Head of Quality, Biologics for Merck Millipore. In this role she was the cluster lead for quality activities in connection with the respective Business and Operations Units. She provided oversight and governance to ensure quality of products, services and suppliers in compliance with external regulations and customer quality requirements
Kate Joined Merck Millipore in July 2010. Before that she worked for AMAG Pharmaceuticals responsible for overall Quality Control and Compliance. She has previously worked for Vertex Pharmaceuticals supporting commercial quality control and held several management positions in quality and research for 3M Medical, Pharmaceutical and Microbiology divisions. She is an experienced leader in all areas of Quality and has broad experience in cGxP and FDA/EU regulations.
Kate received a Doctorate of Philosophy (Ph.D.) in Analytical Chemistry from the University of Minnesota and a Bachelor of Science in Chemistry (ASC) with a minor in Microbiology from the University of Wisconsin-La Crosse.