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Orlaith Greenan

ORLAITH GREENAN

EU/UK LEAD | EXECUTIVE DIRECTOR


Orlaith brings more than 15 years of experience Quality leadership across the life sciences. With a background in Genetics and Cell Biology from Dublin City University, her career spans biotechnology, pharmaceutical development, clinical research, diagnostics, analytical testing and manufacturing. She has worked across GMP, GCP, GLP and ISO-regulated environments, from start-ups to established international organisations.

Orlaith has held senior Quality leadership roles with responsibility for global Quality strategy, regulatory compliance, multi-site Quality teams and Quality Management Systems. Her experience includes establishing and transforming Quality systems, harmonising processes across multiple sites and GxPs, implementing eQMS solutions and providing Quality oversight of early-phase clinical development.

More recently, Orlaith expanded into executive Operations leadership, overseeing Manufacturing, Product Development, Analytical Development, QC, IT and wider business functions. This experience has strengthened her understanding of the operational challenges organisations face and the importance of integrating Quality into everyday processes and decision-making.

She has a particular interest in emerging biotechnology and advanced therapies, alongside the opportunities presented by data integrity, analytics and AI to improve Quality and operational performance.

Orlaith believes effective Quality systems should be proportionate to risk, appropriate to an organisation’s stage of development and designed to support the people and processes that use them. Her approach combines regulatory expertise with practical operational insight, helping organisations achieve compliance without unnecessary complexity.