Sue Busse is Director for global Quality Management Systems at Eli Lilly and Company. In her 20 years at Lilly, she has held assignments in Bioproduct Research and Development, Quality Control for API Manufacturing, and Quality Assurance. In 2004, she began her current position in Global Quality Systems where she is responsible for providing quality systems for Lilly manufacturing and process and product development functions and ensuring that the Quality Systems are integrated within the corporation. In this role, Sue is responsible for the global CAPA program. For ISPE, Sue contributed her knowledge and experience as a member of the PQLI Control Strategy and Illustrative Example teams. She holds a B.S. in Chemistry from the University of Illinois in Champaign/Urbana.