Head of Quality Assurance

Galway

The opportunity

If you're a senior Quality leader who's ready to own the quality agenda of a site end to end, this is one you'll want to hear about.

Our client is an Irish-headquartered pharmaceutical manufacturer supplying medicines to markets right around the world. Now backed by private equity, the business is in an ambitious growth phase: launching new products, opening new markets and preparing for FDA, and they need a Head of Quality Assurance who can lead that next chapter.

This isn't a maintenance role. The site is moving from paper to full digitisation, a new ERP has just gone live, and the business is investing in its people, systems and processes to support its next stage of growth. It's a real opportunity to put your own stamp on how quality is led here.

It's also a genuine career move. You'll report to the Group Head of Quality, Regulatory Affairs and Pharmacovigilance, and this role is seen as the succession pipeline into that group-level position. For the right person, there's a clear path to the top table.

What you'll be doing

You'll lead QA Operations across a predominantly aseptic manufacturing site, with oversight extending to aseptic CMO products and offshore CMOs.

Quality Leadership & Strategy

• Lead and grow the Quality Assurance function, with 3 to 5 direct reports at team lead and manager level across Quality Operations, QMS, Validation and QP.

• Shape and deliver a Quality Strategy that supports the business's growth plans and meets regulatory expectations.

• Build a culture where quality, compliance, accountability and continuous improvement are part of everyday work.

• Set the KPIs and quality metrics that matter, and use them to drive performance.

• Coach and develop your leaders and their teams so they perform at their best and stay engaged.

Quality Operations & Batch Release

• Provide strong, visible quality oversight across manufacturing, packaging, testing, warehousing and distribution.

• Own the batch review, disposition, certification and release process.

• Keep the business clearly informed on batch release status and any emerging quality risks.

• Be a regular voice in daily operations meetings, so quality is built into decisions from the start.
• Support customers on their quality requirements and quality agreements.

Qualified Person Responsibilities

• Act as Primary QP, lead and oversee the site's QP activities.

• Certify batches in line with EU GMP Annex 16 and applicable legislation.

• Make sure every batch is manufactured, tested and released in line with Marketing Authorisations, Technical Agreements and GMP.

• Hold strong oversight of contract manufacturers, suppliers and outsourced activities across multiple jurisdictions.

• Lead or support recall decisions and market actions when needed.

• Keep QP certification records robust and every decision fully traceable.

Quality Management Systems (QMS)

• Govern and continuously improve the Pharmaceutical Quality System, using metrics and trend analysis to stay ahead.

• Oversee document management, change control, deviations, CAPA, complaints, supplier quality, training and management review.

• Lead the rollout, optimisation and governance of a new electronic QMS as the site moves from paper to digital.

Validation Oversight

• Provide strategic direction for equipment, process, cleaning, computerised systems and facility validation.

Regulatory Compliance & Inspection Readiness

• Keep the site compliant with EU GMP, GDP, ICH, FDA and other global requirements, with FDA readiness a key priority.

• Front a busy inspection calendar as the lead quality representative: 30 to 40 customer audits and 3 to 5 regulatory inspections a year, including HPRA, FDA and authorities across Eastern Europe and Latin America.

Risk Management & Continuous Improvement

• Drive improvements that make the quality system more effective and operations more efficient.

• Play a leading role in the digital journey, including eQMS, LIMS and integration with the newly launched ERP.

Stakeholder Engagement

• Build strong partnerships with Manufacturing, QC, Supply Chain, Regulatory Affairs, Engineering, Validation and Technical Services.

• Be the go-to quality contact for regulators, customers, suppliers and external auditors.

• Support new product launches, new market entries and other strategic initiatives, while keeping quality and compliance standards high.

What you'll bring

You're likely a Senior QA Manager or Associate Director in a larger pharma organisation, and you're ready for the step up into a role with real ownership and a path beyond it.

The essentials

• A QP who is actively certifying batches today, not just eligible, and qualified to act as QP within the EU/EEA.

• Hands-on aseptic manufacturing experience. This is non-negotiable.

• 10 to 15 years in pharmaceutical quality within a GMP environment, with at least 5 years leading multidisciplinary quality teams.

• Experience managing quality across multiple jurisdictions, including remote teams or offshore CMOs.

• Front-line experience hosting regulatory inspections, ideally including FDA.

• Expert knowledge of EU GMP (including Annexes 1, 11, 15 and 16), GDP and ICH guidelines.

What will make you stand out

• You've led a digital or eQMS transformation, or worked in a mature electronic QMS environment and know what good looks like.

• You're energised by change. You like rolling up your sleeves, working across functions and making operations better.

• You lead with integrity and a patient-first mindset, and you can influence at every level, from the shop floor to the boardroom.

The search is open to candidates in Ireland and those looking to relocate, including Irish professionals considering a move home. Candidates must hold the right to work in the EU.

For further information on this Head of Quality Assurance role in Galway please contact Caroline Kingston on +353 868395531 or email caroline@hero.ie Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/.

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