Job Description

Lead GMP Auditor (QP)

Permanent | Dublin or Athlone (hybrid) | Development & External QA

The Role

Lead the GMP audit programme across our external manufacturing and supplier network, while acting as a Qualified Person (QP) providing regulatory oversight across clinical and commercial products.

You will independently lead 10+ GMP audits per year, primarily across the US and EU, covering CMOs/CDMOs, suppliers and contract partners, while providing QP oversight of supplier qualification, compliance and regulatory risk.

Key Responsibilities

•     Lead a risk-based programme of GMP audits — CMOs/CDMOs, API suppliers, contract labs, packagers, warehousing and logistics providers.
•     Own supplier quality governance: qualification, re-qualification, audit records (TrackWise), and closure of corrective actions.
•     Act as Qualified Person — QP evaluations, batch certification support, and QP declarations for manufacturing/importation authorisations.
•     Apply quality risk management to audit planning and supplier oversight decisions.
•     Support regulatory inspections and authority interactions for external sites and suppliers.
•     Contribute to and improve the Quality Management System and related procedures.
•     Review third-party audit reports and supplier quality questionnaires, documenting QP evaluations where applicable.
•     Escalate significant GMP compliance or supplier suitability risks to protect product quality and patient safety.
•     Where applicable, extend audit scope to controlled substance handling and DEA-relevant oversight at external CMOs/CDMOs.

Experience & Education

•     BSc in a relevant scientific discipline.
•     MSc or postgraduate Qualified Person qualification.
•     8+ years in pharmaceutical manufacturing, including 4+ years leading GMP audits of CMOs/CDMOs/suppliers.
•     Strong working knowledge of EU and US GMP frameworks.
•     Independent judgement, clear communication, and the ability to manage a complex external supplier network.
•     Expert knowledge of pharmaceutical quality systems, manufacturing and analytical operations.
•     Highly detail-oriented, with strong organisational skills to manage multiple priorities across a complex external supplier network.
•     Analytical and solution-focused, comfortable driving pragmatic, compliant outcomes in a fast-paced environment.

The Next Step for You

If this opportunity is of interest, please send your CV to andile.sibanda@nextgeneration.ie or reach out to discuss the role further.

All applications are treated in the strictest confidence.

Next Generation Recruitment specialises in Supply Chain, Procurement, Engineering, Quality, Technical, Scientific, Manufacturing, and Operations recruitment across permanent, contract, and temporary positions.

Your personal data will never be shared outside our organisation without your prior written consent.