George Serafin

George Serafin is a 35+ year seasoned professional possessing a unique blend of industry, technology, and management consulting experience spanning R&D, engineering, supply chain, manufacturing, quality, regulatory, compliance, corporate/operations, and information technology across medical device and diagnostics, pharmaceuticals, biotechnology, and consumer healthcare.

With his broad and deep knowledge and “concept-to-patient” perspective, George has worked with Top-Ten to pre-revenue companies spanning late-stage development through commercialization and post-market surveillance. He has assisted clients globally (having worked in five continents) in the development and execution of business strategies, that promote innovation and growth, operational efficiency and process excellence, and sustained regulatory compliance.

George is a strategic advisor to the FDA, assisting them in various areas, including product quality, patient safety, advanced manufacturing, data integrity, cloud computing, and digital health. Most recently, he has been supporting FDA’s Case for Quality Initiative, having co-led several projects with the FDA and the Medical Device Innovation Consortium (MDIC) including the Voluntary Improvement Program.

He is recognized as a subject matter expert and has recently testified to the United States International Trade Commission (USITC) and Federal Trade Commission (FTC).

Before joining FTI Consulting, George served in various national and global leadership roles at Grant Thornton and Deloitte & Touche while always serving clients as his top priority. He started his career at Novartis in research and development. He then progressed across the value chain with increasing responsibility in engineering, manufacturing/operations, quality, and regulatory roles working for Roche and Fresenius Medical Care. While at Fresenius, George was part of the management team responsible to address an FDA Consent Decree impacting domestic and international sites and successfully remediated all sites leading to successful termination of the agreement within specified time frame while also still achieving minimal disruption to supply chain and the business.

Subsequently, he transitioned to the technology sector, leading the development, release and maintenance of SAP’s life sciences solution through several critical releases and assisting clients around the globe in the design, development, and implementation of their global enterprise solutions.

He holds a B.E. in Biomedical Engineering with a double minor in Electrical Engineering and Biophysics and a M.S. in Technology Management both from Stevens Institute of Technology.