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Linda Shaw, MT, M.S.O.M., CQA, is an Associate Director of Quality Assurance in the Office of Regulatory Affairs and Quality (ORAQ) within the Duke University School of Medicine. Ms. Shaw manages the Quality Systems Units of the Marcus Center for Cellular Cures (MC3) manufacturing facility. In this role, Ms. Shaw works with a team of Quality Assurance professionals responsible for the oversight of activities surrounding manufacture of a variety of cellular therapies compliant to GMP and GTP standards. Ms. Shaw collaborates with MC3 scientists and investigators in developing and maintaining systems compliant with applicable regulatory standards including training, facilities, equipment, and process appropriate for the phase of clinical development.
Ms. Shaw received her undergraduate degree in Medical Technology from Gannon University (Erie, PA) and her Master’s degree in Operations Management from the University of Arkansas (Fayetteville). Prior to her work at ORAQ, Ms. Shaw served in various Quality manufacturing management roles for Novo Nordisk, Purdue Pharma, Merck, Inc., and Novartis, focusing on Validation, Risk Management, Quality Systems, Auditing & Inspections, and Environmental Monitoring. Ms. Shaw is a Certified Quality Auditor (CQA) in the American Society of Quality (ASQ).