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Narendra Sharma

Founder, Trinity AI University | AI Reskilling for Professionalsย |ย Transforming Life Sciences with AI | Digital Compliance & GxP Leader | Generative AI Strategy | Consultant & Lead Partner | Tech x Regulation

Nashua

7+ years of work experience

SCORE Mentors
Jun 20242 yrs 1 moPresent

New Hampshire, United States

Mentoring for : * Business Plans * Business Development * Technology Strategy * Risk and Compliance * Manufacturing and Quality * Business planning * AI / ML Technology
Trinity Bridge Professional Services
Jul 20233 yrsPresent

New Hampshire, United States

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 firmโ€™s market presence. * Directed advisory services for flagship projects, emphasizing strategic risk assessment and mitigation, ensuring alignment with ambitious client goals and regulatory standards.
FTI Consulting
May 20222 yrs 2 mosJun 2024

Boston, Massachusetts, United States

Directed the Technology Quality, Compliance, and Risk vertical with a commitment to innovation, compliance, and business growth. Empowered the talent pool, guiding the team to pioneer in a competitive, technology-driven market through the adoption and optimization of advanced technologies such as ERP, MES, eQMS, and Cloud services. * Identified the critical need for integrating advanced technologies within regulatory frameworks. * Recognized the potential of AI/ML in advancing medical device safety and security; led the strategic development and execution of AI/ML advancements, reinforcing the company's position at the forefront of healthcare technology innovation. * Established a robust technology risk management framework in compliance with GxP standards, mitigating risks and cementing client trust, thereby making compliance a cornerstone of operational excellence. * Led a multidisciplinary team in developing client-centric IT solutions, significantly enhancing client engagement and satisfaction, and contributing to the firmโ€™s reputation as a leader in technology-driven consulting services.
Moderna
Jul 20236 mosDec 2023

Grant Thornton LLP
Nov 20183 yrs 6 mosApr 2022

Greater Boston Area

Led key advancements in the life sciences sector, focusing on supply chain, digitization, IT/business solutions, and regulatory compliance. Spearheaded transformative initiatives to enhance quality, efficiency, and cost-effectiveness across the board, driving innovation and operational excellence in a fast-evolving Cell and Gene therapy CDMO space. * Pioneered the introduction of AI and ML technologies within procurement and GxP environments, enhancing operational processes and setting new standards for technological innovation in the sector. * Engineered a quality assessment framework for M&A activities, identifying compliance risks and leading due diligence efforts, resulting in strategic portfolio expansions and heightened compliance security. * Instituted a Covid Pandemic Risk-based response and analytics framework, alongside Waterfall and Agile SDLC frameworks, improving project delivery timelines and the quality of IT services and solutions. * Championed the seamless implementation of ERP systems across multiple sites for a Cell and Gene therapy CDMO, significantly streamlining operations and achieving a landmark of zero FDA observations during PAI audits.

Education

Boston University

MS, Project Management

Boston University

Indian Institute of Technology, Roorkee

BE, Chemical Engineering

Indian Institute of Technology, Roorkee

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Headline

Founder, Trinity AI University | AI Reskilling for Professionals | Transforming Life Sciences with AI | Digital Compliance & GxP Leader | Generative AI Strategy | Consultant & Lead Partner | Tech x Regulation

About

With over 30 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. * ๐’๐ž๐ซ๐ฏ๐ž๐ ๐š๐ฌ ๐ˆ๐ง๐ญ๐ž๐ซ๐ข๐ฆ ๐‚๐ˆ๐Ž: Guiding firms through critical digital transformations and IT restructures, ensuring strategic continuity and cybersecurity. * ๐‹๐ž๐ ๐„๐ง๐ญ๐ž๐ซ๐ฉ๐ซ๐ข๐ฌ๐ž-๐–๐ข๐๐ž ๐ƒ๐ข๐ ๐ข๐ญ๐š๐ฅ ๐“๐ซ๐š๐ง๐ฌ๐Ÿ๐จ๐ซ๐ฆ๐š๐ญ๐ข๐จ๐ง: Directed technology quality, compliance, and risk, driving innovation and business growth through advanced digital strategies. * ๐‚๐ก๐š๐ฆ๐ฉ๐ข๐จ๐ง๐ž๐ ๐ƒ๐ข๐ ๐ข๐ญ๐š๐ฅ ๐š๐ง๐ ๐๐ซ๐จ๐œ๐ž๐ฌ๐ฌ ๐“๐ซ๐š๐ง๐ฌ๐Ÿ๐จ๐ซ๐ฆ๐š๐ญ๐ข๐จ๐ง: Streamlined operations and ensured seamless ERP implementations across multiple sites, enhancing operational efficiency and compliance. * ๐‘๐ž๐œ๐จ๐ ๐ง๐ข๐ณ๐ž๐ ๐‹๐ž๐š๐๐ž๐ซ ๐ข๐ง ๐ˆ๐ง๐ญ๐ž๐ ๐ซ๐š๐ญ๐ข๐ง๐  ๐ƒ๐ข๐ ๐ข๐ญ๐š๐ฅ ๐’๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ: Integrated digital solutions to enhance operational efficiency, compliance, and patient safety, delivering high-quality management systems. I founded Trinity AI University to solve a problem I kept seeing in professional services: teams spending on AI tools but not developing the skills to use them well. Trinity offers structured AI skills training โ€” starting with a free AI Readiness Assessment that tells you exactly where you sit and what to focus on next. If you or your team are building AI capability seriously, start at edu.trinitybps.com

Location

Nashua

Work experience

Startup Mentor (Volunteer) at SCORE Mentors, Jun 2024 - Present ยท 2 yrs 1 mo, New Hampshire, United States, Mentoring for : * Business Plans * Business Development * Technology Strategy * Risk and Compliance * Manufacturing and Quality * Business planning * AI / ML Technology

Lead Partner at Trinity Bridge Professional Services, Jul 2023 - Present ยท 3 yrs, New Hampshire, United States, 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 firmโ€™s market presence. * Directed advisory services for flagship projects, emphasizing strategic risk assessment and mitigation, ensuring alignment with ambitious client goals and regulatory standards.

Managing Director Health Solutions at FTI Consulting, May 2022 - Jun 2024 ยท 2 yrs 2 mos, Boston, Massachusetts, United States, Directed the Technology Quality, Compliance, and Risk vertical with a commitment to innovation, compliance, and business growth. Empowered the talent pool, guiding the team to pioneer in a competitive, technology-driven market through the adoption and optimization of advanced technologies such as ERP, MES, eQMS, and Cloud services. * Identified the critical need for integrating advanced technologies within regulatory frameworks. * Recognized the potential of AI/ML in advancing medical device safety and security; led the strategic development and execution of AI/ML advancements, reinforcing the company's position at the forefront of healthcare technology innovation. * Established a robust technology risk management framework in compliance with GxP standards, mitigating risks and cementing client trust, thereby making compliance a cornerstone of operational excellence. * Led a multidisciplinary team in developing client-centric IT solutions, significantly enhancing client engagement and satisfaction, and contributing to the firmโ€™s reputation as a leader in technology-driven consulting services.

Digital Compliance Leader at Moderna, Jul 2023 - Dec 2023 ยท 6 mos

Senior Manager/Director (SMD) at Grant Thornton LLP, Nov 2018 - Apr 2022 ยท 3 yrs 6 mos, Greater Boston Area, Led key advancements in the life sciences sector, focusing on supply chain, digitization, IT/business solutions, and regulatory compliance. Spearheaded transformative initiatives to enhance quality, efficiency, and cost-effectiveness across the board, driving innovation and operational excellence in a fast-evolving Cell and Gene therapy CDMO space. * Pioneered the introduction of AI and ML technologies within procurement and GxP environments, enhancing operational processes and setting new standards for technological innovation in the sector. * Engineered a quality assessment framework for M&A activities, identifying compliance risks and leading due diligence efforts, resulting in strategic portfolio expansions and heightened compliance security. * Instituted a Covid Pandemic Risk-based response and analytics framework, alongside Waterfall and Agile SDLC frameworks, improving project delivery timelines and the quality of IT services and solutions. * Championed the seamless implementation of ERP systems across multiple sites for a Cell and Gene therapy CDMO, significantly streamlining operations and achieving a landmark of zero FDA observations during PAI audits.

Education

MS, Project Management, Boston University

BE, Chemical Engineering, Indian Institute of Technology, Roorkee