Head of Quality Assurance

Job location: Ireland

Head of Quality, Risk & Compliance

Location: Dublin South

Contract: Permanent

An established healthcare organization operating within a highly regulated clinical environment is seeking an experienced Head of Quality, Risk & Compliance to join its Senior Management Team.

This is a pivotal leadership role responsible for the strategic development, implementation, and continuous improvement of the organization’s Quality, Risk, and Compliance framework. The successful candidate will ensure full regulatory adherence, maintain accreditation and certification standards, and drive a culture of quality, safety, and operational excellence.

Responsibilities:

Lead and maintain the Quality Management System (QMS) to ensure regulatory compliance with EU and Irish legislation governing tissues and cells.

Act as primary liaison with regulatory, certification, and accreditation bodies, managing inspections, reporting obligations, and license variations.

Oversee incident management systems including non-conformances, complaints, serious adverse events/reactions, and CAPA processes.

Drive internal audit programs, validation activities, and equipment compliance frameworks.

Lead organizational risk management and insurance coordination.

Ensure compliance with Wholesale Distribution Authorisation (WDA) and Good Distribution Practice (GDP) requirements where applicable.

Develop KPIs and performance reporting mechanisms to support strategic objectives.

Manage departmental budgets and identify opportunities for efficiency and improvement.

Lead and develop a multidisciplinary quality team, fostering professional growth and high performance.

Contribute at senior leadership level to organizational strategy, innovation, and service improvement.

Essential Requirements:

Degree qualification in Quality, Healthcare, or related discipline.

Minimum 5 years’ experience in a senior management role within a regulated environment.

Demonstrated experience managing regulatory inspections and compliance frameworks.

Strong leadership, stakeholder engagement, and communication skills.

Desirable:

Experience in healthcare or fertility.

Experience in Good Distribution Practice (GDP).

Familiarity with ISO 9001 and accreditation standards.

This is an excellent opportunity for a strategic quality leader to shape governance standards within a dynamic healthcare setting with an organization that is passionate about patient outcomes.