Karen Hughes is a performance driven and accomplished Quality Assurance Professional with over 30 years of experience in the pharmaceutical, biotechnology, and medical device industry from drug discovery and development through commercialization. She 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 Laboratories. Areas of expertise include Quality System development, implementation, maintenance and continuous improvement, quality auditing, risk management, employee training, and quality event investigations.