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Kara Quinn has over 25 years experience in the Biopharmaceutical industry supporting large molecule (biologics & vaccine) development, commercialization, and licensure through a range of disciplines including Quality, Regulatory, Process Technology, and Clinical. Currently at Merck & Co., Inc., Kara serves as a subject matter expert in the fit-for-use qualification of procured raw materials. Her participation in the Drug Substance BioPhorum Group has enabled her to collaborate with industry peers and co-lead the Raw Material Risk Management workstream in the development of a quantitative tool for raw material risk assessment.