Basic Summary:

The Head of Quality Assurance is responsible for providing strategic and operational leadership of the Quality Assurance function, ensuring compliance with applicable GMP, GDP, regulatory and company requirements. The role has overall responsibility for Quality Operations, Quality Management Systems (QMS), Validation, and Qualified Person (QP) activities, ensuring the Pharmaceutical Quality System (PQS) remains effective, inspection-ready, and aligned with business objectives.

The role is also responsible for fostering a culture of quality, compliance, continuous improvement, and patient safety while leading cross-functional collaboration across manufacturing, quality control, supply chain, regulatory affairs, and technical operations. The role provides oversight of batch certification and release activities, quality systems governance, validation programmes, regulatory inspections, and quality risk management.

Location: Based 5 days onsite at our facility in Loughrea, Co Galway. This role is eligible for hybrid working (3 days onsite, 2 days remote) after completion of 6 month probationary period.

As our Head of Quality Assurance your key responsibilities will be as follows:

Quality Leadership & Strategy

Lead and develop the Quality Assurance organisation, including Quality Operations, QMS, Validation, and QP personnel.
Define and execute the Quality Strategy aligned with company objectives and regulatory expectations.
Promote a culture of quality, compliance, accountability, and continuous improvement.
Establish and monitor departmental KPIs and quality metrics.
Provide leadership and mentorship to quality teams to ensure high performance and engagement.

Quality Operations & Batch Release

Ensure robust quality oversight of manufacturing, packaging, testing, warehousing, and distribution activities.
Oversee batch review, disposition, certification, and release processes.
Ensure timely communication of batch release status and quality-related risks.
Participate in daily operational meetings to ensure quality considerations are integrated into business decisions.
Provide quality support for customer requirements and quality agreements.

Qualified Person Responsibilities

Act as Primary Qualified Person (QP) or provide oversight of QP activities.
Certify medicinal product batches in accordance with EU GMP Annex 16 and applicable legislation.
Ensure batches are manufactured, tested, and released in compliance with Marketing Authorisations, Technical Agreements, and GMP requirements.
Maintain appropriate oversight of contract manufacturers, suppliers, and outsourced activities.
Support product recall decisions and market action activities as required.
Maintain QP certification records and ensure traceability of decisions.

Quality Management Systems (QMS)

Ensure effective governance and continuous improvement of the Pharmaceutical Quality System through quality metrics and trend analysis..
Oversee document management, change control, deviations, CAPA, complaints, supplier quality management, training, and management review processes.
Lead implementation, optimisation, and governance of electronic Quality Management Systems (eQMS).

Validation Oversight

Provide strategic leadership for equipment, process, cleaning, computerised systems, and facility validation programmes.

Regulatory Compliance & Inspection Readiness

Ensure ongoing compliance with EU GMP, GDP, ICH guidelines, FDA requirements, and other applicable regulations.
Serve as the primary quality representative during regulatory inspections.

Risk Management & Continuous Improvement

Drive continuous improvement initiatives to enhance quality system effectiveness and operational efficiency.
Support digital transformation initiatives including eQMS, LIMS, and other quality-related systems.

Stakeholder Engagement

Build effective partnerships with Manufacturing, QC, Supply Chain, Regulatory Affairs, Engineering, Validation, and Technical Services.
Act as the primary quality contact for regulatory authorities, customers, suppliers, and external auditors.
Support strategic business initiatives while ensuring quality and compliance requirements are maintained.

Qualifications & Experience:

Education

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.

Experience

Minimum 10 years' experience in pharmaceutical quality roles within a GMP-regulated environment.
Minimum 5 years' leadership experience managing multidisciplinary quality teams.
Demonstrated experience in Quality Operations, Quality Systems, Validation, and regulatory inspections.
Experience supporting or certifying commercial product batches.
Proven track record of leading complex quality improvement and compliance initiatives.

Technical Knowledge

Expert knowledge of EU GMP, Annex 1, Annex 11, Annex 15, Annex 16, GDP, and ICH guidelines.
Strong understanding of Pharmaceutical Quality Systems and Quality Risk Management principles.
Experience with eQMS, validation lifecycle management, and inspection readiness programs.
Knowledge of regulatory expectations from HPRA, EMA, FDA, MHRA, and other global authorities.

Key Competencies

Strategic Leadership
Regulatory & GMP Expertise
Quality Systems Management
Risk-Based Decision Making
People Leadership & Talent Development
Inspection and Audit Management
Business Partnership & Influencing Skills
Change Management
Continuous Improvement
Strong Communication and Stakeholder Management
Integrity, Accountability, and Patient Focus

Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.

Head of Quality Assurance

Job Description