Karen Wathen

Karen Wathen has over 30 years of experience in quality operations and assurance within the biopharmaceutical industry. Currently serving as Associate Director of Quality Operations at REGENXBIO Inc. since June 2016, previous roles include Senior Manager and Senior Quality Associate at the same company. Prior to REGENXBIO, Karen held the position of Manufacturing Specialist at NOVAVAX INC. and worked as a Quality Assurance Specialist at GlaxoSmithKline. Experience also includes significant roles at Human Genome Sciences as a Quality Assurance Specialist, Quality Control Analyst, and Research Associate. Expertise encompasses bulk drug product disposition, process assessment, deviation review, root cause analysis, CAPA, investigation team leadership, and audit.