Kara Quinn, senior consultant, joined ValSource Consulting in 2021. She was previously employed with Merck & Co., Inc. for about 28 years providing process technical and auality systems support across small and large molecule product portfolios. Kara has end-to-end pharmaceutical experience supporting non/clinical development, process technology transfer, validation, commercialization, licensing, PAIs and quality management systems support for market supply. Kara honed her skills as a subject matter expert in the fit-for-function qualification of bio/pharmaceutical raw materials and novel excipients. She led a team of industry peers in the development and publication of a practical tool for Raw Material Risk Assessments.