Lorraine McClain is currently Senior Director, Quality Risk Management, at Teva Pharmaceuticals. A professional with over 25 years of experience 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, quality metrics, and risk management. Lorraine joined Teva after its acquisition of Cephalon where she was responsible for corporate quality systems, and previously held positions of increasing responsibility at Johnson & Johnson Ortho Diagnostic Systems, Immulok, and as an independent Quality Assurance consultant. Lorraine holds a Master of Arts degree in Biology from the University of California Santa Barbara. She is an active member of the ISPE Quality Metrics Team.