Janet Rose Rea


Janet Rose Rea, is a consultant for the biopharmaceutical industry and the principal in her company, QARA Services, LLC. Ms. Rea was also a faculty member at the U of W, providing a current industry perspective in the BioMedical Regulatory Affairs, where she had been a frequent lecturer since 1999. She held the position of Vice President, Regulatory Affairs and Quality at Poniard Pharmaceuticals (previously NeoRx), from 2008 – 2010 and AVI BioPharma from 2003 – 2008. She was also a corporate officer for both organizations. Trained as a public health microbiologist at the University of Washington, Ms. Rea started her career with American Dade Division, American Hospital Supply Corporation in Miami Florida in the microbiology quality assurance group, applying microbiological techniques to improve aseptic processing and reducing product failure. Thereafter, she returned to Seattle, working for Genetic Systems, Immunex – where she played a key role in the approval of the company’s first product, LEUKINE®, MDS Panlabs, and Targeted Genetics. Her diverse experience transcends the product development continuum in a variety of therapeutic areas, especially oncology and rare genetic diseases. She has been active in training and lecturing on a variety of compliance topics. She is a member of two Editorial Advisory Boards, and has lectured extensively as well as published. She received a Bachelor of Science in Microbiology and was conferred a Master of Science of Public Health (MSPH) from the University of Washington, Seattle WA.

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Implementing cGMP to produce investigational drug and biologic products can be a challenge for an organization.  A full systems required ...