Narendra Sharma

Narendra Sharma has more than 26 years of process transformation experience in manufacturing, supply chain, quality management, digitization, IT strategy, acquisition and divesture, risk management, and project/portfolio management. He has helped to achieve business goals, build capabilities, strengthen controls, manage risks and enhance organizational health, while focused on patient safety. He possesses global experience across multiple industries, with extensive client service and employee work in North America, South America, Europe, and Asia.

Mr. Sharma has worked with manufacturing, pharmaceutical, medical device, cell & gene therapy, supply chain, and health consumer companies to achieve process efficiencies, information technology, quality, and compliance objectives. He is skilled in assisting companies in defining strategic objectives, establishing a winning team, and delivering results within set timeline, budget and quality parameters. His efforts have resulted in optimized operating models, including the establishment of Centers of Excellence and hybrid models, through the implementation of frameworks focused on the right level of compliance and business objectives. He has experience executing risk-based projects, while managing small and global teams.

Before joining FTI consulting, Mr. Sharma held key leadership roles at Grant Thornton, Deloitte, Philips Medical Systems and Wyeth Biopharma, in addition to large- and medium-scale chemical companies. To name some highlights from his career, he has helped carry out various ISO 9000 implementations, helped transform a chemical facility into a pharmaceutical-grade facility, set up frameworks for IT that supported various software development lifecycle (SDLC) frameworks, and supported supply chain and quality function digitization and automation processes.

During Mr. Sharma's time at Grant Thornton, acting as the Senior Managing Director of IT, he gained valuable experiences with the Oracle ERP system, Sarbanes-Oxley Act (SOx) compliance standards, as well as completed many quality management system (QMS) assessments and successful end-to-end client proposal lifecycles. While at Deloitte, he executed GxP (“good practice” regulations and guidelines) quality initiatives to ensure they met FDA requirements, utilized GxP-compliant software in both agile and waterfall environments, and he also gained knowledge of software as a medical device (SaMD), robotic process automation (RPA), and cognitive learning validation.

Mr. Sharma holds a B.E. in chemical engineering from the Indian Institute of Technology and an M.S. in project management from Boston University. He is a member of the Regulatory Affairs Professionals Society and the International Society of Pharmaceutical Engineers.