Sheeba Nair

With over 20 years of experience in quality assurance and auditing in clinical research, I lead the Quality Governance Organization at Accenture, overseeing the quality management system for data management, pharmacovigilance, and regulatory affairs. I have a proven track record of establishing and maintaining high-quality standards and compliance across diverse and complex clinical research projects, including first-in-man, bioavailability, bioequivalence, dermatological, and personal healthcare studies. Managing client audits and regulatory Inspections. A GXP auditor managing internal and vendor audits.

As a certified Six Sigma and Lean Sigma professional, I apply a strategic and practical approach to deliver robust quality assurance and compliance solutions in the dynamic field of clinical research. I have successfully hosted regulatory inspections, conducted vendor audits, managed internal audit programs, and coordinated QA resources globally. I am also skilled in issue management, root cause analysis, CAPA monitoring, change and deviation management, and vendor management. I am committed to enhancing organizational performance by providing staff training on quality systems and GxP requirements, and by working collaboratively in a multicultural environment.