Lead GMP Auditor & QP - External Manufacturing Quality

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

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