QA Director: Digital QMS & Regulatory Readiness

HERO Recruitment Ltd.; Galway; On-site; EUR 120,000 - 180,000; Full time

Job summary

HERO Recruitment Ltd. is partnering with an Ireland-based pharmaceutical manufacturer in Galway to appoint a Head of Quality Assurance.

The role provides end-to-end ownership of quality across the site, with a move from paper to digital systems and an ERP go-live to support aggressive growth. The successful leader will certify batches, oversee QMS, regulatory inspections and international quality standards, and report to the Group Head of Quality, Regulatory Affairs and Pharmacovigilance.

Qualifications

• Must hold an EU/EEA-qualified Person (QP) certificate and certify batches today.
• Extensive experience in aseptic manufacturing and multi-jurisdiction oversight.
• Proven track record in leading quality teams and regulatory inspections.

Responsibilities

• Lead QA Operations across manufacturing, packaging, testing, warehousing and distribution.
• Own batch review, disposition, certification and release processes.
• Set KPIs, drive continuous improvement, and oversee QMS and regulatory readiness.
• Lead or support regulatory inspections (FDA, HPRA) and audits.
• Drive digital journey with eQMS, LIMS and ERP integration.

Skills

Quality leadership

Regulatory readiness

Cross-functional leadership

Digital transformation

QA strategy

Education

EU QP certification

Tools

eQMS

LIMS

ERP integration

Job description

HERO Recruitment Ltd. is partnering with an Ireland-based pharmaceutical manufacturer in Galway to appoint a Head of Quality Assurance.

The role provides end-to-end ownership of quality across the site, with a move from paper to digital systems and an ERP go-live to support aggressive growth. The successful leader will certify batches, oversee QMS, regulatory inspections and international quality standards, and report to the Group Head of Quality, Regulatory Affairs and Pharmacovigilance.