The Lead GMP Auditor & Qualified Person is responsible for providing independent GMP audit leadership and quality oversight of the company’s external manufacturing and supplier network, supporting clinical and commercial products across sterile and non sterile operations.
The position can be fully office based in either the Dublin or Athlone office or on a hybrid basis. The role is accountable for the governance, execution, and ongoing management of the external audit programme and for maintaining effective GMP oversight of Contract Manufacturing Organisations, Contract Laboratories, suppliers, vendors, and logistics providers, in accordance with EU and US regulatory requirements.
The role provides expert GMP and Qualified Person input to supplier qualification, quality risk management, and regulatory compliance activities, and supports inspection readiness and regulatory authority interactions related to external operations.
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