Senior GMP Quality Auditor – External Supply Oversight

The RFT Group; Leinster; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

The RFT Group, BioPharmaceutical Division, is seeking a Lead GMP Quality Auditor in Ireland. The role provides independent GMP audit leadership and oversight of external manufacturing and supplier networks across sterile and non-sterile operations.

Hybrid or office-based in Ireland, with EU/US regulatory alignment and Qualified Person input. Responsibilities include governance of the external audit programme, supplier qualification, and risk-based audit delivery.

Qualifications

• BSc in a relevant scientific discipline required.
• Qualified Person eligible is preferred.
• Expert knowledge of pharmaceutical quality systems and EU/US GMP.

Responsibilities

• Provide independent, risk-based leadership of GMP audits across external suppliers and contract partners.
• Lead audits in accordance with EU and US regulatory requirements and maintain the external audit programme.
• Oversee supplier qualification, QMS records, and CAPA tracking until closure.
• Manage audit schedules for CMOs/CDMOs and suppliers based on risk and regulatory expectations.
• Act as a Qualified Person where applicable to support supplier compliance assessments.

Skills

GMP audits

External supplier oversight

Regulatory knowledge

Qualified Person eligible

Risk-based leadership

Independent judgement

Education

BSc in a relevant scientific discipline

Qualified Person eligible

Job description

The RFT Group, BioPharmaceutical Division, is seeking a Lead GMP Quality Auditor in Ireland. The role provides independent GMP audit leadership and oversight of external manufacturing and supplier networks across sterile and non-sterile operations.

Hybrid or office-based in Ireland, with EU/US regulatory alignment and Qualified Person input. Responsibilities include governance of the external audit programme, supplier qualification, and risk-based audit delivery.