Amy Mutere
About Amy Mutere
Amy Mutere is the Sr. Director of Vector External Manufacturing Quality at Bristol Myers Squibb and Juno Therapeutics, Inc./BMS in Seattle, Washington, with extensive experience in quality management across various technologies and regulatory compliance.
Current Positions
Amy Mutere is currently employed at Bristol Myers Squibb in Seattle, Washington, where she holds the position of Sr. Director Vector External Manufacturing Quality. Concurrently, she is also engaged with Juno Therapeutics, Inc., a subsidiary of BMS, focusing on Cell Therapy External Manufacturing and Supply Chain Quality.
Previous Roles in Biopharmaceutical Quality Management
Amy has held significant roles in quality management across various prominent biopharmaceutical companies. At Roche, she served as Executive Director, Head of Global Quality Inspection Management from 2016 to 2021 in Basel Area, Switzerland. Prior to that, she was with Genentech, where she worked in various capacities including Executive Director, Head Global Quality Inspection Management (2014-2021), Global Quality Inspection Management EU Head (2011-2014), and Associate Director Supplier Quality Americas Region (2008-2011), all in South San Francisco, California.
Early Career and Long-Term Role
Prior to her tenure at Genentech and Roche, Amy Mutere was the Quality Site Head at Research Organics, SAFC in Cleveland, Ohio, where she served from 1994 to 2008. During this 14-year period, she developed and honed her expertise in quality management and compliance for various biopharmaceutical products and technologies.
Educational Background
Amy's academic background is rooted in chemistry, with a Bachelor of Arts in Chemistry from The College of Wooster and a Bachelor of Science in Chemistry from Kent State University. She further advanced her education with a Master of Science in Environmental Chemistry from the University of Nairobi. These academic credentials laid the foundation for her extensive career in quality management within the biopharmaceutical industry.
Expertise in Biopharmaceutical Quality and Compliance
Amy Mutere brings a wealth of expertise in managing quality for diverse technologies such as excipients, plasmids, vectors, CAR-T, drug products, and biologics. She specializes in inspection readiness and PLI/PAI with a strong focus on transitioning technical teams from early phases to approval stages. Amy possesses in-depth knowledge of regulatory compliance across major global markets, including FDA, EMA, Cofepris, ANVISA, China, and Russia. Her professional activities also include external influencing interactions and fostering mutual reliance.