2024 PDA/FDA Joint Regulatory Conference

Denyse D. Baker, PE, RAC Eli Lilly and Company

Denyse D. Baker, PE, RAC

Denyse D. Baker, PE, RAC Eli Lilly and Company

Denyse Baker is the Associate Vice President, External Engagement and Advocacy, for the Global Quality Compliance organization at Eli Lilly. She is passionate about connecting and collaborating to develop science-based regulation and organizational quality culture as to enable production of high quality products for patients. Denyse has a strong technical foundation to her policy work with experience in engineering, manufacturing, quality and regulatory for small molecules, biologics and devices. Denyse returned to Lilly in December 2022 following work experience with the US FDA, the Parenteral Drug Association, and AstraZeneca. She is a member of the Global Quality Management WG at PhRMA, Vice-Chair of PDA’s Regulatory and Quality Advisory Board, Co-leader of the PDA Quality Management Maturity Task Force, and secretary to the FDA Alumni Association Board of Directors. Denyse holds a B.S. in Mechanical Engineering from Northwestern University, is a licensed professional engineer, and earned RAC certifications in US and EU Reg Affairs.