Karen Hughes

Karen Hughes is a performance-driven and accomplished quality assurance professional with more than 30 years of experience in the pharmaceutical, biotechnology, and medical device industry from drug discovery and development through commercialization. Karen has a wide range of knowledge in GLP, GMP, GCP, ISO, and DEA regulations and ICH guidelines. She previously worked as a Quality and Compliance Consultant at Meridian BioGroup, a Pace Life Sciences Company, and has held quality assurance positions of increasing responsibility at Synthetic Biologics, Pharmaceutics International, Inc., Emergent BioSolutions, MGI Pharma (formerly Guilford Pharmaceuticals), and Chesapeake Biological Laboratory. Karen’s areas of expertise include quality system development, implementation, maintenance, and continuous improvement, quality auditing, risk management, employee training, and quality event investigations.