Lesley Merkle

After graduating at 7500 feet above sea level with a B.A. in English and B.S. in Zoology from Northern Arizona University, I started my journey in GMP at the American Red Cross in Tucson. I then moved to New England to be closer to the Boston Biotech Hub and landed at Genzyme which offered opportunities for growth at the Biosurgery and Biologics divisions. The last 9 years of my 21 year career in Quality at Genzyme/Sanofi have focused on implementing and managing the Quality Risk Management Program. As an Associate Director of Quality Compliance and Site Risk Champion for Sanofi Framingham Biologics, I develop and deploy the annual site quality risk plan. This includes implementing, for each product, the growing body of new risk tools such as Viral, Cross-Contamination and Mix-up, Nitrosamine, BSE/TSE, Monosource, Holistic Contamination Control, Elemental Impurities, Excipients, Low Endotoxin Recovery, and the upcoming newcomer to the show, Phthalates and Bisphenols. Risk management excites me because any problem or process can be assessed with existing or custom risk methodology.