Lead, GMP Auditor

Alkermes; Dublin; Hybrid; EUR 120,000 - 150,000; Full time

Benefits offered by this job

Hybrid work model

Office presence in Dublin/Athlone

Job summary

Alkermes seeks a Lead GMP Auditor & Qualified Person to provide independent audit leadership and quality oversight of the company’s external manufacturing and supplier network across sterile and non‑sterile operations. The role covers governance, execution, and ongoing management of the external audit programme in line with EU/US GMP requirements.

The position can be office-based in Dublin or Athlone or on a hybrid basis, with travel for approximately 5 external audits per year within Europe and

Qualifications

• BSc in a relevant scientific discipline.
• MSc or postgraduate Qualified Person qualification.
• Minimum of 8 years’ experience in pharmaceutical manufacturing.
• At least 4 years’ experience conducting or leading GMP audits of CMOs, CDMOs, and/or suppliers.
• Proven ability to lead GMP audits independently and communicate outcomes clearly.

Responsibilities

• Lead GMP audits and manage external audit programme.
• Provide QP input to supplier qualification and regulatory compliance activities.
• Support inspection readiness and regulatory authority interactions.
• Oversee governance and quality oversight of external manufacturing and supplier network.

Skills

GMP auditing

Quality management systems

Auditing

Regulatory knowledge (EU/US)

Risk assessment

Travel readiness

Education

BSc in science

MSc Qualified Person

Job description

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.

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.

Responsibilities

This role combines batch release, quality metrics management, and lead auditing responsibilities.

Essential Requirements

• QP eligible (the candidate does not need to be licensed or have worked as a QP; however, we value the qualification and the experience gained in obtaining it).
• Extensive experience working within pharmaceutical quality management systems.
• Strong technical knowledge of solid oral dose manufacturing processes.
• Experience as a Lead GMP Auditor. We will assess auditing competency during the interview process rather than requiring a minimum number of completed audits.
• Willingness to travel for approximately 5 external audits per year, primarily within Europe and the East Coast of the USA.
• Technical knowledge of sterile manufacturing processes.

Qualifications

• BSc in a relevant scientific discipline required.
• MSc or postgraduate Qualified Person qualification required.
• Demonstrated expert knowledge of pharmaceutical quality systems, manufacturing and analytical operations, with a deep understanding of EU and US GMP regulatory frameworks and their application to external manufacturing and supplier networks.
• Minimum of 8 years’ experience in the pharmaceutical manufacturing industry, including at least 4 years’ experience conducting or leading GMP audits of CMOs, CDMOs, and/or suppliers.
• Proven ability to lead GMP audits independently, apply risk‑based judgement, and communicate audit outcomes, expectations, and compliance risks clearly and effectively to internal stakeholders and external partners.
• Strong professional judgement, integrity, and independence, with the ability to assess complex quality and compliance issues and elevate risks appropriately.
• Team‑oriented and quality‑focused, with the ability to collaborate effectively across quality, technical, regulatory, and operational functions.
• Highly detail‑oriented, with strong organisational skills and the ability to manage multiple priorities across a complex external supplier network.
• Analytical and solution‑focused, with the ability to identify improvement opportunities, evaluate root causes, and drive pragmatic, compliant outcomes.
• Adaptable and comfortable operating in a dynamic, fast‑paced environment, with a proactive approach to continuous improvement and regulatory readiness.