Mereena Kurien

I’m a Global Quality & Compliance leader with 25+ years across FDA- and EU-regulated pharmaceutical and biotechnology organizations, where I drive enterprise GMP/GDP compliance, inspection readiness, and QMS governance. I’m trusted to lead product disposition and global batch release decisions that protect patient safety while maintaining uninterrupted commercial supply.

In my current role as Manager, Global Quality Systems, I provide enterprise quality governance across commercial manufacturing, testing, packaging, and distribution, supporting compliant supply across U.S. and EU markets. I partner cross-functionally to influence risk-based recommendations for regulatory strategy, product disposition, and CAPA execution, and I serve as a senior QA authority balancing compliance with business continuity.

I’ve led QMS transformation and digital enablement, including enterprise eQMS strategy and implementation using Veeva Vault QMS, and I’ve supported global CMO and supplier quality strategies. Earlier in my career, I supported sterile manufacturing quality leadership at Takeda and began in R&D for chemistry and microbiology, including analytical method development/validation and CTD submission content for FDA and global filings.