Senior GMP Audit Lead & QP for External Partners

QA Resources Ltd; Dublin; Hybrid; EUR 90,000 - 130,000; Full time

Job summary

QA Resources Ltd is seeking a highly experienced Quality Auditor to lead GMP audits of external partners across EU and US and to provide independent QP oversight for external manufacturing and supplier activities.

The role is hybrid based in Dublin or Athlone, with extensive travel within US and EU and accountability for audit governance, quality risk management and regulatory readiness in line with EU and US GMP expectations.

Qualifications

• BSc in a relevant scientific discipline required.
• Expert knowledge of pharmaceutical quality systems, manufacturing and analytical operations, with a deep understanding of EU and US GMP regulatory frameworks.
• 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.

Responsibilities

• Lead GMP audits of external partners and suppliers across EU and US locations.
• Oversee supplier qualification and requalification activities and audit schedules.
• Maintain audit and supplier records within the Quality Management System (e.g., TrackWise).
• Provide Qualified Person oversight and input into regulatory compliance activities.
• Support regulatory inspections and authority interactions related to external sites and suppliers.
• Escalate GMP compliance risks and provide risk-based advice to stakeholders.

Skills

Audit leadership

QA systems

Regulatory knowledge

CRO/CMO auditing

Independent judgement

Communication

Teamwork

Analytical thinking

Education

BSc in a relevant scientific discipline

Tools

TrackWise

Job description

QA Resources Ltd is seeking a highly experienced Quality Auditor to lead GMP audits of external partners across EU and US and to provide independent QP oversight for external manufacturing and supplier activities.

The role is hybrid based in Dublin or Athlone, with extensive travel within US and EU and accountability for audit governance, quality risk management and regulatory readiness in line with EU and US GMP expectations.