Head of Quality Assurance | Loughrea, Co. Galway
HERO Recruitment is partnering with an established pharmaceutical manufacturer in Galway to appoint a Head of Quality Assurance. This senior leadership role carries full ownership of the site’s quality function and a real opportunity to shape quality strategy and culture.
The Role
You’ll lead the QA organisation across Quality Operations, QMS, Validation and QP activities, keeping the Pharmaceutical Quality System effective, inspection-ready and aligned with the business. Key areas include:
- Setting and delivering the Quality Strategy, KPIs and a strong culture of quality and continuous improvement
- Overseeing batch review, certification and release, acting as Primary QP or overseeing QP activities under EU GMP Annex 16
- Governing the QMS, including change control, deviations, CAPA, complaints, supplier quality and eQMS
- Providing strategic leadership of validation programmes covering equipment, process, cleaning, CSV and facility
- Acting as the primary quality contact for HPRA, FDA and other regulators, customers and auditors, and leading inspections
- Partnering closely with Manufacturing, QC, Supply Chain, Regulatory and Technical teams
What You’ll Bring
- A degree in Pharmacy, Pharmaceutical Science, Life Sciences, Engineering or a related discipline
- Must be a Qualified Person (QP), eligible to certify batches within the EU/EEA
- 10+ years in pharmaceutical quality roles, including 5+ years leading multidisciplinary teams
- Hands-on experience certifying or supporting commercial batch release
- Expert knowledge of EU GMP (Annexes 1, 11, 15 and 16), GDP and ICH, with a strong track record in regulatory inspections
Working Pattern
The role is fully onsite in Loughrea for the first 6 months. After that, it moves to hybrid working: 3 days onsite and 2 days remote.
Interested? This search is being managed by HERO Recruitment. For a confidential conversation, message me directly or apply here.