Lead GMP Quality Auditor (QP Eligible)

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

Lead GMP Quality Auditor (QP eligible)

Our client is a highly successful, and ambitious global biopharmaceutical company with a strong commercial portfolio and product development pipeline. They now wish to hire a Lead GMP Quality Auditor within their global team. The position can be fully office based at one of several sites in Ireland / or on a hybrid basis, within Ireland.

The Lead GMP Quality Auditor 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 role is accountable for the governance, execution, and ongoing management of the external audit programme and for maintaining effective GMP oversight of CROs, Contract Laboratories, suppliers, vendors, and logistics providers, in accordance with EU and US regulatory requirements. The role operates with a high degree of autonomy, integrity, and objectivity, maintaining appropriate independence from operational and commercial pressures.

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. The position operates with a high degree of professional independence and judgement, consistent with HPRA and EU GMP expectations for a Senior GMP Quality Auditor. Quality Auditor Certification and Qualified Person are highly desirable.

Responsibilities for Lead GMP Quality Auditor

• Provide independent, risk-based leadership of GMP audits across external suppliers and contract partners supporting clinical and commercial products, including sterile and non-sterile operations.
• Audits are performed to EU and US regulatory requirements and support ongoing compliance of the external manufacturing and supply network. The role is accountable for delivery of a robust external audit programme, typically involving 10+ audits per year mainly across US and EU locations.
• In addition to leading GMP audits, maintain responsibility for supplier quality management activities, including maintenance of audit and supplier records within the QMS. Ensure that audit outcomes, supplier compliance status, commitments, and corrective actions are appropriately documented, risk-assessed, and tracked to timely and effective closure.
• Manage supplier qualification and re-qualification activities, including oversight of audit and supplier re-qualification schedules, ensuring that CMOs, CDMOs, and suppliers remain suitable for their intended scope of use based on risk, audit outcomes, and regulatory expectations.
• Issue and review supplier quality questionnaires and assess third-party audit reports, documenting a Qualified Person evaluation where applicable to support supplier compliance assessments and oversight decisions.
• Act as a Qualified Person in accordance with EU GMP legislation, providing independent QP oversight and regulatory judgement in support of external manufacturing and supplier activities.
• Maintain current knowledge of EU and US GMP legislation, HPRA and EMA expectations, and relevant regulatory guidance, and apply this knowledge to audit strategy, supplier oversight, and Qualified Person assessments.
• Support regulatory inspections, audits, and authority interactions related to external sites, suppliers, and products, including inspection preparation, provision of subject-matter expertise during inspections, and input to regulatory responses and commitments where required.
• Contribute to the effective operation and continuous improvement of the QMS through involvement in quality activities relevant to external supplier oversight and auditing.
• Ensure GMP audit oversight includes assessment of controlled substance handling and compliance at external CMOs/CDMOs and suppliers.

Requirements for Lead GMP Auditor

• BSc in a relevant scientific discipline required.
• Qualified Person eligible.
• 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.
• 8+ years' experience in the pharmaceutical manufacturing industry, including at least 2+ years' experience conducting or leading GMP quality 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 escalation risks appropriately.
• Team-oriented and quality-focused, with the ability to collaborate effective 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 and evaluate root causes and drive pragmatic, compliant outcomes.

For further details please contact Larry on [phone] / [e-mail]

The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie