Lead, GMP Auditor

Alkermes; Dublin; On-site; EUR 60,000 - 80,000; Full time

Job summary

Alkermes is seeking a Lead GMP Auditor & Qualified Person to oversee the GMP audit leadership and quality oversight of our external manufacturing and supplier networks. This role can be fully office-based in Dublin or Athlone or on a hybrid basis.

The successful candidate will manage the external audit program, ensuring compliance with EU and US regulatory requirements, and provide expert input on quality risk management and regulatory compliance activities.

Qualifications

• Experience in auditing GMP processes and quality oversight in a regulated environment.
• Understanding of EU and US regulatory requirements.
• Expertise in supplier qualification and quality risk management.

Responsibilities

• Provide independent GMP audit leadership.
• Manage and oversee external audit programs.
• Support inspection readiness and interactions with regulatory authorities.

Job description

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.