Location: Dublin or Athlone (hybrid or fully office-based)
We're seeking an experienced Lead GMP Auditor & Qualified Person to provide independent GMP audit leadership and quality oversight across our external manufacturing and supplier network, spanning clinical and commercial products in both sterile and non-sterile operations.
30% travel, primarily to East coast U.S.
Reporting to the Director, Quality Assurance, you'll lead a risk-based external audit programme (10+ audits per year across the US and EU) covering CMOs/CDMOs, API and raw material suppliers, contract laboratories, packagers, warehousing, and logistics providers. You'll also act as a Qualified Person under EU GMP legislation, providing QP assessment of external sites, supplier risk evaluations, and regulatory input, with potential support for QP batch certification of non-sterile products.
What you'll bring:
- BSc in a relevant scientific discipline; MSc or postgraduate QP qualification
- Minimum 8 years in pharmaceutical manufacturing, including 4+ years leading GMP audits of CMOs, CDMOs, and/or suppliers
- Deep knowledge of EU and US GMP regulatory frameworks, HPRA/EMA expectations, and quality risk management principles
- Proven ability to lead audits independently, exercise sound professional judgement, and communicate compliance risks clearly across internal and external stakeholders
- Strong integrity, independence, and attention to detail, with the ability to manage a complex, global supplier network
This is a senior, high-autonomy role for a QP-qualified auditor who wants to shape GMP compliance strategy across a diverse external manufacturing network