Narendra Sharma

About Narendra Sharma

With over 29 years of transformative leadership, I bring extensive experience across multiple domains. As a veteran in life sciences digital strategy and business co-founder, I\'ve catalyzed process improvements, strengthened digital and IT strategy, and led risk management within the biotechnology and life sciences sectors. My experience includes steering organizations towards operational excellence in Manufacturing, Pharmaceutical, Medical Device, and Cell & Gene Therapy fields, crafting compliant and cutting-edge Quality Management Systems (QMS). Renowned for analytical skills in unraveling complex issues, marshaling high-performance teams, and forging strong executive partnerships, I\'ve synchronized global operations with a steadfast focus on compliance, efficiency, and patient safety. My expertise spans North America, South America, Europe, and Asia, enriching my ability to drive impactful change.*: Guiding firms through critical digital transformations and IT restructures, ensuring strategic continuity and cybersecurity.*: Directed technology quality, compliance, and risk, driving innovation and business growth through advanced digital strategies.*: Streamlined operations and ensured seamless ERP implementations across multiple sites, enhancing operational efficiency and compliance.*: Integrated digital solutions to enhance operational efficiency, compliance, and patient safety, delivering high-quality management systems.Skills:* Business Transformation & Digital Innovation * Global Strategic Planning & Execution * Quality Management Systems (QMS)* Team Leadership & Talent Development * Executive Relationship Building * Analytical Problem Solving | Strategic Partnership Development * Project & Program Management | Cross-Functional Team Collaboration * IT Strategy & Infrastructure * Regulatory Compliance & Risk Management * Artificial Intelligence Strategist

Experience

1. Lead Partner

   Trinity Bridge Professional Services

   Jul 2023 — Present · NH, US

   Driving enterprise-wide digital transformation with a focus on integrating advanced risk management and regulatory compliance frameworks into core business strategies. Renowned for championing the development of regulatory compliance and quality assurance methodologies, addressing the complexities of cyber risks specific to the life sciences industry.* Identified gaps in digital transformation strategy, led the development and implementation of a tailored framework that integrated with regulatory compliance, resulting in enhanced operational efficiency and client satisfaction.* Spearheaded the adoption of cutting-edge cyber risk management practices, significantly reducing vulnerability to cyber threats and aligning with industry-best standards.* Facilitated strategic partnerships with top-tier stakeholders in the life science ecosystem, driving business growth and expanding the firm’s market presence.* Directed advisory services for flagship projects, emphasizing strategic risk assessment and mitigation, ensuring alignment with ambitious client goals and regulatory standards.

Education

• Indian Institute of Technology, Roorkee

  BE, Chemical Engineering

• Boston University

  MS, Project Management

Skills

• Training
• Testing
• Process Improvement
• Iso
• Business Process Improvement
• Sop
• Fda
• Medical Devices
• Capa
• Iso 9000
• Quality Management
• Quality System
• V&V
• Integration
• Process Simulation
• Project Portfolio Management
• Management
• Program Management
• Software Documentation
• Sdlc
• Strategy
• Gamp
• Itil
• Continuous Improvement
• Six Sigma
• Project Management
• Sap
• Change Management
• Process Engineering
• Change Control
• Business Analysis
• Computer System Validation
• Software Development
• 21 Cfr Part 11
• Process Optimization
• Engineering
• Validation
• Team Leadership
• Erp
• Quality Assurance