QA Leader: Strategy, QMS & Compliance (Hybrid)

HireHive; Loughrea; Hybrid; EUR 120,000 - 150,000; Full time

Job summary

HireHive seeks a Head of Quality Assurance to provide strategic leadership of QA, quality operations, QMS, validation, and QP activities. You will ensure the Pharmaceutical Quality System remains inspection-ready and aligned with business objectives, while fostering a culture of quality and patient safety across cross-functional teams.

The role includes oversight of batch certification and release, regulatory inspections, CAPA, and continuous improvement.

Qualifications

• Degree in Pharmacy, Pharmaceutical Science, Quality Assurance, Engineering, Life Sciences, or a related discipline.
• Eligibility to act as a Qualified Person (QP) within the EU/EEA.

Responsibilities

• Provide strategic and operational leadership for Quality Assurance, Quality Operations, QMS, Validation, and QP activities.
• Oversee batch review, disposition, certification, and release processes.
• Ensure compliance with EU GMP, GDP, ICH guidelines, FDA requirements and other regulations.
• Lead continuous improvement, risk management, and regulatory inspections readiness.
• Build strong partnerships with Manufacturing, QC, Regulatory Affairs, Engineering, and Supply Chain.

Skills

Strategic Leadership

Regulatory GMP Expertise

Quality Systems Management

Risk Management

People Leadership

Inspection & Audits

Stakeholder Management

Change Management

Continuous Improvement

Communication Skills

Integrity & Patient Focus

Education

Degree in Pharmacy, Pharmaceutical Science, Quality Assurance, Engineering, Life Sciences, or related discipline

Eligibility to act as a Qualified Person (QP) within the EU/EEA

Tools

eQMS

LIMS

Job description

HireHive seeks a Head of Quality Assurance to provide strategic leadership of QA, quality operations, QMS, validation, and QP activities. You will ensure the Pharmaceutical Quality System remains inspection-ready and aligned with business objectives, while fostering a culture of quality and patient safety across cross-functional teams.

The role includes oversight of batch certification and release, regulatory inspections, CAPA, and continuous improvement.