About

Narendra Sharma is a highly experienced IT Quality and Regulatory Risk professional, with over 27 years of experience working with Pharmaceutical, Biotech, Medical device, Chemical, and software companies. He is currently the Managing Director and VP at FTI Consulting, where he has established a proven track record in IT Risk Management, Quality Management Systems, FDA Regulatory Compliance, System Remediation, SaMD implementation, application Change Management systems, Compliance control implementation, and the implementation of validation/quality/testing center of excellence. Narendra has worked with a number of high-profile companies, including Grant Thornton and Deloitte, where he has successfully led Quality, supply chain, manufacturing, and IT functional transformation initiatives. He has implemented Quality Strategies, startups, FDA / SOx regulatory readiness assessment and gap remediation, FDA facility inspection readiness, continuous improvement initiatives, IT Portfolio assessment and maturity, and AI and machine learning implementations, among others. He is also experienced in designing and executing Organization Change, Communications, Transformation, and Training initiatives, and has developed Covid Pandemic Risk-based response frameworks and analytics, Waterfall and Agile framework implementations, Risk-based project delivery, Quality metrics, and dashboards. Narendra holds an MS in Project Management from Boston University, as well as certifications in PRINCE2, ITIL v3 Foundation, Solution Manager, Writing Validation Protocols, SAP R/3 PP/MM module, ABAP/4, PLC programming, and CMMI Appraiser. He has a strong background in Chemical Engineering, having studied at the Indian Institute of Technology, Roorkee. Narendra is also proficient in a range of tech stacks, including AI, AWS, Kubernetes, Jenkins, Docker, Ansible, Terraform, Python, Microservices, Azure, Selenium, and Web. With almost 21 years of relevant experience, Narendra is a highly skilled and accomplished professional in his field. He is passionate about serving in areas such as Acquisition and Divestitures, Quality Management Systems, Cyber Security and Security Risk Management, Quality and CSV functional transformation, Project Management and Project Execution, Center of excellence initiatives, SaMD compliance framework, and RPA / Cognitive learning enabled systems validation framework.