Priya Annamalai

Inspection Program - Quality Operations Quality Assurance

Astellas Pharma global Development, Inc.

Bio:

Priya Annamalai
With over 20 years of global experience in regulatory inspections and GxP quality systems, Priya Annamalai is a seasoned Quality and Compliance leader specializing in inspection readiness and execution. She currently serves as Director of Quality Operations (Inspection Program) at Astellas, where she leads global GCP, GLP, and PV inspection management activities, supporting major regulatory submissions and health authority engagements. Priya's expertise includes inspection strategy, CAPA oversight, regulatory intelligence, process excellence, quality management systems, and auditing. She has successfully directed large-scale, multi-agency inspections and is known for her collaborative leadership and ability to drive proactive compliance across complex development portfolios.