Head of Quality Assurance

Hero Recruitment Group; Galway; Hybrid; EUR 110,000 - 150,000; Full time

Job summary

HERO Recruitment Group in Ireland 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.

You will lead QA across Quality Operations, QMS, Validation and QP activities, ensuring the Pharmaceutical Quality System is inspection-ready and aligned with the business.

Qualifications

• Must be a Qualified Person (QP), eligible to certify batches within the EU/EEA.
• 10+ years in pharmaceutical quality roles with 5+ years leading multidisciplinary teams.
• Deep knowledge of EU GMP (Annexes 1, 11, 15 and 16), GDP and ICH.
• Experience certifying or supporting commercial batch release.
• Strong leadership and strategic quality mindset.

Responsibilities

• Lead QA across Quality Operations, QMS, Validation and QP activities.
• Maintain an inspection-ready Pharmaceutical Quality System.
• Set and deliver Quality Strategy and KPIs.
• Oversee regulatory inspections and liaise with HPRA, FDA and auditors.
• Partner with Manufacturing, Regulatory and Technical teams.

Skills

Leadership

Regulatory knowledge

Quality management

Cross-functional collaboration

Auditing/Inspection readiness

Education

Degree in Pharmacy, Pharmaceutical Science, Life Sciences, Engineering

QP certification (Qualified Person)

Job description

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.