Quality Specialist GMP – Dublin | 12117.

This Quality Specialist GMP job in Dublin is a 9–12 month fixed-term maternity cover contract offering €55,000–€60,000 (DOE) within a global pharmaceutical organisation operating under U.S. FDA and EU EMA regulatory frameworks. Based in Ballsbridge on a hybrid working model, you will support commercial product release to the United States while overseeing core Quality Management System (QMS) activities across internal manufacturing sites and Contract Manufacturing Organisations (CMOs). Working within a regulated cGMP (Current Good Manufacturing Practice) environment (see: Pharmaceutical GMP & Regulatory Glossary), you will review batch documentation, assess deviations and change controls, and ensure products meet regulatory standards prior to release to the U.S. market. The role combines technical batch oversight, compliance review, investigation support and inspection readiness, making it suitable for a scientifically qualified quality professional with pharmaceutical GMP experience who understands regulatory documentation integrity and risk-based decision making. Applicants must currently reside in Ireland with valid work authorisation.