Lorraine McClain is currently an independent quality consultant working with Nabriva Therapeutics. A professional with over 25 years in the pharmaceutical and medical diagnostics industries, Lorraine has extensive experience in global quality systems design and implementation, quality assurance, and compliance. She has directed global, multidisciplinary projects resulting in effective process improvements and enhanced compliance outcomes. Areas of specialty include supplier quality, product complaint management, quality standards, change management, investigations, document management, quality metrics, and quality risk management. Lorraine was formerly Senior Director Quality Risk Management at Teva Pharmaceuticals and prior to that Director Corporate Quality Systems at Cephalon. She previously held positions of increasing responsibility at Johnson & Johnson Ortho Diagnostic Systems and Immulok. Lorraine holds a Master of Arts degree in Biology from the University of California Santa Barbara. She was formerly a member of the ISPE Quality Metrics Team with a focus on metrics definitions.