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George Serafin

George Serafin

  • Senior Managing Director
  • Health Solutions
  • T: +1 212 841 9352
  • M: +1 973 722 3922
  • F: +1 212 841 9350
Connect with Me:
    • Three Times Square
    • 9th Floor
    • New York, NY, 10036
    • United States
    • T: +1 212 247 1010
    • F: +1 212 841 9350

George Serafin is a Senior Managing Director at FTI Consulting. He is a member of the Health Solutions practice and is based in New York. Mr. Serafin serves as the life sciences industry leader responsible for the integrated delivery of services and solutions focused on assisting life sciences clients with solving their most complex problems and achieving their strategic and operational objectives.

Mr. Serafin has 30+ years of experience in the areas of R&D, engineering, manufacturing, supply chain, quality control/laboratory, quality assurance, regulatory, compliance, corporate/operations, and information technology across pharmaceutical, biotechnology, medical technology, and consumer healthcare.

With Mr. Serafin’s broad and deep knowledge and “molecule-to-patient” perspective, Mr. Serafin has work in and assisted clients across five continents in the development and execution of business and risk strategies that promote innovation and growth, operational efficiency and process excellence, and sustained regulatory compliance involving business process transformation and technology enablement including enterprise systems, digital technology, cloud computing, intelligent automation, and advanced analytics.

Mr. Serafin has demonstrated domestic and international regulatory compliance experience including ANVISA, CMS, DEA, EMA, FDA, GCP/PV, GxP, HC, ICH, ISO, MHLW, MHRA, NMPA, PDMA, and PIC/S including product submission/approvals, site registrations, 483/Warning Letter/Consent Decree, response and remediation program development and execution. He is internationally recognized for his subject matter knowledge and experience concerning regulatory, quality, compliance, and risk management.

Mr. Serafin is a strategic advisor to the FDA having assisted them in various areas including product quality, data integrity, cloud computing, and digital health. For the last several years, he has been co-leading a collaboration effort between FDA, the Medical Device Innovation Consortium (MDIC), and the medical device industry that has developed a program that leverages CMMI (Capability Maturity Model Integration) as the standard maturity model by which medical device organizations may measure their capability to produce high quality devices and improve patient safety.

Prior to consulting, Mr. Serafin worked for Novartis, Roche, and Fresenius Medical Care, starting in research and development, and then progressing across the value chain with increasing levels of responsibility in engineering, manufacturing/operation, quality, and regulatory. He also worked for SAP and led the development of SAP’s Life Sciences solution and served as its life sciences solutions leader.

Mr. Serafin received an M.S. in Technology Management and a B.E. in Biomedical Engineering from Stevens Institute of Technology.

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