Bianna Gal brings extensive Quality Assurance (QA) compliance and GMP (Good Manufacturing Practice) experience to Cell One Partners. As a Quality Systems consultant for cell & gene therapies, biologics, vaccines, small molecules, and combination products, she has supported biopharmaceutical companies in establishing robust Quality Systems and GMP manufacturing processes in the US and Canada. With over 20 years of experience in the biopharmaceutical and pharmaceutical industries, Bianna has led Quality Operations for multiple virtual companies in clinical development. She has developed GxP-compliant quality systems and provided quality oversight of GMP manufacturing at contract manufacturing organizations across Phase 1-3 clinical trials in the US and globally. Her expertise includes developing and implementing Quality Systems to adhere to GMP standards, ensuring rigorous compliance and operational excellence.

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Her previous roles include Director of GMP Quality Assurance at Gates Medical Research Institute, where she oversaw monoclonal antibody manufacturing. At IRX Therapeutics, Bianna served as Director of Quality Assurance, where she managed the day-to-day operations and staff of the QA department. She developed and implemented QMS system, internal and external audit programs, as well as qualification programs for raw material suppliers and contractors. At Pfizer Global Manufacturing, she supported product launches and oversaw pharmaceutical product releases. Bianna's comprehensive QA and GMP experience make her an invaluable asset to Cell One Partners.