Head of Pharma Quality (IRE)

Head of Pharma Quality

Full Time Permanent

CityWest

Role
The Head of Pharma Quality role is responsible for providing strategic leadership and operational oversight of all pharmaceutical activities conducted within Ireland, ensuring full compliance with applicable Ireland and EU regulatory requirements which govern GxP activities, advertising compliance and Medical Devices. 

This role provides strategic quality leadership, governance, and assurance that all applicable EU GDP/GMP, GxP, pharmacovigilance, and regulatory requirements are met, while supporting sustainable business growth.

Responsibilities 
Governance and Regulatory
•    Ensure compliance with Irish and EU pharmaceutical legislation, including GDP, GVP and where applicable GMP.
•    Ensure activities remain compliant with regulatory, ethical, PV, advertising and promotional regulations.
•    Define and lead the pharma quality strategy aligned with Group Quality objectives. 
•    Lead inspection readiness activities and act as senior quality representative during regulatory inspections and audits.
•    Act as a senior quality leader and decision-maker, providing expert input into business strategy, sourcing models, and market expansion.
•    Ensure quality governance supports patient safety, product integrity, and regulatory compliance.
•    Maintain governance over product release and traceability. 
•    Provide quality leadership for the governance and execution of new programs or business. 
•    Provide pharmaceutical expertise supporting product launches and lifecycle management.
•    Ensure clear accountability and oversight of outsourced and intercompany activities through quality agreements and governance forums.
•    Oversight of regulatory and quality compliance for early access programmes, compassionate use programmes, name patient supply and expanded access initiatives. 
•    Foster a strong culture of quality, compliance, and continuous improvement.

Quality Management System 
•    Oversight of operations conducted under Wholesale Distribution Authorisation (WDA).
•    Ensure effective quality management systems including deviation management, CAPA, change control, complaints, audits, risk management, and training.
•    Supplier qualification and oversight. 
•    Ensure GDP-compliant storage, transportation, and distribution of medicinal products.
•    Maintain oversight of Responsible Person (RP) activities and GDP compliance programmes.
•    Support Responsible Person decision-making through robust quality oversight and governance.
•    Liaise with the Group QP for MIA activities where required.
•    Ensure supplier qualification, temperature control management, and recall systems are maintained.
•    Support licence applications, variations and maintenance of current licences. 
•    Serve as a senior quality contact for health authorities including HPRA and other competent authorities.
•    Ensure alignment between Irish operational practices and global governance frameworks.

Leadership and Stakeholder Engagement 
•    Lead, coach, and develop quality teams.
•    Report outcomes, trends, and key risks to executive leadership. 
•    Act as a senior partner to the leadership team and foster a culture of Continuous Improvement.
•    Promote cross‑regional collaboration and knowledge-sharing.
•    Establish strong working relationships with internal stakeholders, external partners, regulators, and clients.
•    Ensure regional and site leaders understand and accept responsibility for remediation.
•    Maintain Uniphi communication and presence. 

Assurance & Risk Management
•    Provide independent assurance on the effectiveness of quality systems, internal controls, and regulatory compliance.
•    Identify systemic issues and cross-functional risks across global operations.
•    Drive continuous improvement initiatives in governance, quality, and control frameworks.

Key Skills and Experience

Essential 
•    Extensive experience in regulated pharmaceutical or life sciences environments.
•    Deep expertise in GxP regulations (GMP, GDP, GCP) and global regulatory frameworks.
•    Strong knowledge of ISO standards and quality management systems.
•    Proven leadership of quality assurance functions.
•    Ability to engage credibly with regulators, senior leadership, and audit committees.

Desirable
•    Quality or regulatory qualifications (e.g. QP, RQAP, ISO Lead Auditor).
•    Experience managing regulatory inspections or major compliance programmes.