Mary Guthrie Leedy

Mary Guthrie Leedy has extensive experience in quality assurance and quality systems management within the biopharmaceutical industry. Mary currently holds the position of Associate Director of Quality Assurance at Lyell Immunopharma, where they are responsible for managing routine QA operations and providing leadership to the QA team. Prior to this role, Mary worked as an Associate Director of Quality Assurance at Zymergen, where they oversaw product disposition and risk mitigation activities for R&D and commercial portfolios. Mary also played a key role in developing internal policies, procedures, and training guides to ensure quality expectations were met throughout the product lifecycle. Before Zymergen, Mary worked as a Quality Assurance Manager at Astellas Pharma US, where they established new quality systems and successfully resolved major observations during audits. Mary also has experience as a Quality Assurance Specialist at Alder Biopharmaceuticals Inc., where they were responsible for lot disposition activities and ensuring compliance across multiple organizations. Mary's earlier work experience includes roles as a Quality Systems Supervisor at Seqirus, a Quality Systems Specialist and Production Engineer at Novartis, a Process Engineering Intern at Novozymes, and an Administrative Assistant at NC State Puropse Institute. Mary holds a degree in Chemical Engineering from North Carolina State University.

Mary Guthrie Leedy attended John T. Hoggard High School from 2001 to 2004. Mary then pursued a Bachelor's degree in Chemical and Biomolecular Engineering at North Carolina State University from 2004 to 2009. In 2009, they also attended IAE FRANCE - Écoles Universitaires de Management, where they earned a Master's degree in Global Innovation Management. Mary also obtained additional certifications, including an Advanced Certificate for Microsoft Excel 2010 and a Deviation Certification and Root Cause Analysis Trainer certification.