Stephen Nava joined Sunesis in September 2015 as Executive Director CMC, transitioned to Executive Director, Quality Assurance and Compliance and is now is Vice President, Quality Assurance, Compliance and Regulatory Affairs. Mr. Nava joined Sunesis from Regulatory Affairs, Quality Assurance Consulting Services, Inc. where he currently serves as Principle/Owner from 2004. Previously, he was Director, Regulatory Affairs and Quality Assurance for BiPar Sciences, Inc., a wholly owned subsidiary of Sanofi, and Director, Regulatory Affairs, at Acumen Sciences, LLC. Mr Nava is a trained ISO-9000 auditor with 24 years of experience in the research and development of drugs and biopharmaceuticals. He has extensive experience in developing and maintaining phase appropriate quality management systems including pre-approval inspection readiness in accordance with cGMP compliance. Over his career, he has assessed multiple organizations across intermediates/key starting materials, drug substance, parenteral, solid oral dosage, topical and medical device manufacturing operations within the United States, Europe, China, Japan, Southeast Asia and India. His experience in CMC Regulatory Affairs strategy includes early stage development (IND/CTA) to late stage commercial launch (NDA/MAA) for small molecules and biologics, including monoclonal antibodies and antibody-drug conjugates.
Mr. Nava holds a Bachelor of Science in Chemistry/Math from Texas A&I University-Kingsville, Texas.