Quality Assurance/Regulatory Affairs Professional with 30+ years of experience in cGMP compliance and quality systems. Stephen is an ISO9000-trained auditor with a solid foundation in worldwide quality and regulatory requirements and a thorough knowledge of cGMP guidelines. His experience includes auditing vendors for phase appropriate clinical development through mock-PAI readiness. Completed 100+ audits across the supply chain including intermediates/key starting materials, biologically active substance, drug substance, parenteral, solid oral dosage, topical and medical device manufacturing operations within the United States, Europe, China, Japan, Southeast Asia, and India. Experience includes both small, and large molecules (i.e., monoclonal antibodies (mAb), Antibody-drug conjugates (ADC), Biosimilars, and Bispecific antibodies (bsAbs)). Developed/Managed quality assurance/regulatory affairs, compliance, and medical writing departments. Implemented phase-appropriate quality systems, managed supply chains, provided CMC regulatory submission strategy for both US and ex-US dossiers, authored modules 2 and 3 for INDs, IMPDs, NDAs and MAAs in eCTD format and provided oversight for project technology transfer of manufacturing/analytical operations.In addition to consulting, Stephen recently held the position of Vice President, Quality Assurance, Compliance and Regulatory Affairs at Sunesis Pharmaceuticals, Inc.; prior to Sunesis, he was Director, Regulatory Affairs/Quality Assurance at BiPar Sciences, Inc., a wholly owned subsidiary of Sanofi, for 6.5 years.