Permanent
Lead GMP Auditor (QP
Posted on 04 September 26 by Andile Sibanda
- Dublin, Ireland
- €0 - €0 per Annum
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Job Description
Lead GMP Auditor / Dublin or Midlands
A global audit role, at the centre of a fast-growing pharma quality team
This is a rare opportunity to lead GMP audits across a genuinely international network of CMOs, CDMOs and suppliers — spanning the US and Europe — for a pharmaceutical business that is scaling quickly and investing heavily in its quality function.
You'll be the person on the ground: visiting manufacturing sites, meeting the people running them, and making the calls that keep a global supply chain compliant and moving. If you want a role with real travel, real autonomy and real ownership, this is it.
What makes this role different
- You'll see the world of pharma manufacturing first-hand. Regular travel to CMO and CDMO sites across the US and Europe — this isn't a desk-bound compliance job.
- You'll own the audit programme. You'll shape how it runs, not just execute someone else's plan. Around 10+ audits a year, and real scope to put your stamp on how the function operates.
- You'll join a team that's growing. The company is expanding fast, and this role sits right at the heart of that growth — with the visibility and career runway that comes with it.
- You'll be trusted to lead. This is a senior, independent role. You'll make judgement calls on supplier compliance and risk, and be the expert voice when it matters.
What you'll be doing
- Leading GMP audits of external manufacturing partners, laboratories and suppliers — API, drug product, packaging, storage and logistics — across sterile and non-sterile operations.
- Building and maintaining strong working relationships with CMOs and CDMOs, so oversight is collaborative, not just a paper exercise.
- Assessing supplier quality, risk and compliance on an ongoing basis, and making clear, well-reasoned recommendations.
- Supporting regulatory inspections and audits, bringing your expertise to the table when it counts.
- Working closely with quality, technical and regulatory teams to keep the external supply network audit-ready at all times.
What you'll bring
- A relevant scientific degree, with strong, hands-on experience in pharmaceutical GMP.
- At least 4 years leading or conducting GMP audits of CMOs, CDMOs or suppliers.
- Confidence to travel internationally and represent the company on-site.
- Sound judgement, independence and the ability to communicate clearly — with internal teams and external partners alike.
- A proactive, solutions-focused mindset — someone who spots the issue and helps fix it.
Qualified Person qualification is not required — we're looking for strong audit experience and judgement first and foremost.
The details
Based in Ireland, with a flexible, hybrid working pattern. Great benefits, genuine progression, and a seat at the table in a quality team that's building something new.
Ready to see where this role could take you? Get in touch.
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.
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