Karen has over 28 years of experience in Quality Assurance and management for biologics, antibodies, ADCs, and cell and gene therapies. Prior to her consulting career Karen served as Quality Manager and Quality Engineer with hands on engagement and oversight of change control, management of non-conformance records, annual product review, product disposition, warehouse operations, and document creation and control for recombinant proteins and vaccine products at some of the leading biopharma companies including Amgen, Sandoz, KBI Biopharma, Medtronic, Guidant Vascular and Mentor Medical. She has specialized in Quality Assurance for commercial production from raw materials through finished product distribution; however, her expertise spans Supplier Quality Management, Validation/Qualification, Change Control, Deviation/OOS Investigations, CAPA implementation, Annual Process Review, New Product Introductions, Process Improvements, and Project Management. Karen is PMP certified and holds a Six-Sigma Green belt. Karen received her B.S. in Mechanical Engineering from UC Santa Barbara, and an MBA from Webster University in Netherlands.