Harshit Prajapati is a results-driven senior validation and compliance leader with over 12 years of experience in regulated life sciences environments, delivering enterprise-wide compliance and validation programs supporting GMP, GCP, and regulated laboratory and quality environments, with experience across broader GxP frameworks. He brings deep expertise in Computer Systems Validation (CSV), Computer Software Assurance (CSA), and risk-based methodologies, serving global biotechnology and pharmaceutical organizations across FDA, EMA, and other international regulatory landscapes.
Currently serving as Senior Manager of IT Validation & Compliance at CRISPR Therapeutics, Harshit oversees global IT validation programs supporting advanced therapy manufacturing and enterprise platforms. He established a Global IT Compliance Program integrating CSA principles, developed an enterprise data discovery and governance framework, and serves as the primary IT Compliance representative interface during FDA, EMA, SOX, and privacy audits, reporting compliance metrics and strategic recommendations to senior leadership.
Previously at bluebird bio, Harshit progressed from CSV Project Engineer to Manager of IT GxP Compliance, leading validation of clinical chain-of-custody systems and managing audit findings and CAPAs.Earlier roles at Boston Technology Research and Validation Associates LLC strengthened his expertise across research and development (R&D), manufacturing, clinical, laboratory, and enterprise business systems, supporting both cloud-based SaaS platforms and traditional on-premises environments.
Harshit holds a Master of Science in Regulatory Affairs from Northeastern University, a Bachelor of Science in Pharmaceutical Sciences from the University of Toledo, and a Cybersecurity Certificate from Cornell University, combining scientific rigor, regulatory depth, and technology awareness into a comprehensive professional profile. Beyond GxP compliance, Harshit has played a key role in SOX IT General Controls (ITGC) programs and enterprise audit readiness initiatives, partnering with business leaders, quality organizations, and external auditors to coordinate control testing, evidence management, and governance activities across complex technology environments