Narendra has more than 29 years of process transformation and management experience in Manufacturing, Supply Chain, Quality Management, Clinical Trial Management, Digitization, IT Strategy, Acquisition and Divestiture, Risk management, and Project / Portfolio Management to achieve business goals, build capabilities, strengthen controls, manage risks and enhance organization health while focused on patient safety.
Dynamic and accomplished executive with a proven track record in leading technology and quality initiatives within the life sciences sector, currently serving as Partner and CEO at Trinity Bridge Professional Services, LLC. Expert in driving digital transformation, regulatory compliance, and client business development. Skilled in navigating complex environments at high-profile clients, implementing digital compliance transformation, and agile validation frameworks.
Previously held leadership roles at FTI Consulting and Grant Thornton LLP, demonstrating exceptional abilities in technology quality, compliance, risk management, and supply chain process optimization. At Deloitte & Touche LLP, led life science IT quality initiatives and managed large-scale IT systems compliance assessments and remediations. Instrumental in establishing global test management functions and compliance reporting frameworks at Philips Medical Systems.
Possess a solid educational background with an MS in Project Management from Boston University and a Bachelor of Engineering from IIT Roorkee. Hold multiple professional certifications, including, CMMI assessment, Six Sigma Lean, Prince 2, and ITIL v3 Foundation.
Key competencies include Quality Assurance Management, FDA Regulatory Compliance, Software Validation Lifecycle, Cybersecurity, Project Management, Artificial Intelligence and Business Strategies, and Agile Methodology. Recognized for leadership in Organizational Change Management, Process Improvement, and Data Integrity, with a strong focus on customer satisfaction and operational excellence.
Narendra is an Honored Listee by Marquis Who's Who March 24 - Dec 29.
Ali Faruqi
With a comprehensive Bio-Pharma industry background spanning nineteen (19) years, Ali brings expertise in Digitalization, Design Thinking, Technology and Quality Management.
This extensive experience encompasses various facets: a remarkable fifteen (15) years dedicated to shaping Digital Data & Technology strategies, including proof of concept, development, and implementation; over fifteen (15) years devoted to adept Risk Management; more than seventeen (17) years immersed in IT Quality and Compliance, specifically in R&D and Quality systems; a decade (10) of proficiency in Digital Workforce Automation; and a robust eighteen (18) years of mastery in Portfolio & Program Mgmt.
Beyond his professional achievements, he is an avid explorer, frequently embarking on global travels and cherishing quality time with my family. Additionally, he has channeled his passion for soccer into coaching for a remarkable span of nine years with a new passion for coaching Pickleball (PTR Certified Coach).
Managing PartnerManaging Partner, CreZenTech LLC
Siddhartha Jain
Siddhartha has nearly two decades of experience in the biopharmaceutical industry with expertise in CMC and new ways of working including through digital transformation and innovation. He has led teams and built new capabilities in the areas of process development, Manufacturing Sciences, Material Science, R&D, Digital Transformation and Quality at various leading global biopharmaceutical companies. He has supported the commercial manufacturing and/or contributed to the commercialization of multiple biologics drugs. Siddhartha is currently leading Shoolin Management Company (SMC), a Biologics CMC consulting company that is aimed at enabling the biopharmaceutical companies define the value proposition and strategy, implement and achieve the potential of digital transformation, artificial intelligence / machine learning and other innovative technologies. To learn about how SMC can help your organization, please contact Siddhartha.
President, Shoolin Management Company (SMC)
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