Location: Dublin (with travel to additional clinical sites as required)
Quality Manager to oversee and continually improve the Quality Management System (QMS) across multiple clinics and an associated pharmaceutical distribution operation.
About the Role
Reporting to the Head of Quality, Risk & Compliance, the Quality Manager will lead the Quality team and ensure compliance with EU Directives, Irish legislation, HPRA guidance, ISO 9001:2015, and CHKS accreditation requirements.
The role also includes acting as Responsible Person for a wholesale distribution facility operating under a Wholesale Distribution Authorisation (WDA), ensuring compliance with Good Distribution Practice (GDP) and managing all regulatory interactions.
This role offers the opportunity to work within a collaborative, multidisciplinary environment where professionalism, communication, and leadership are highly valued.
Key Responsibilities
Quality Management System (QMS) & Performance
Lead and support non-conformance, complaint and change‑control investigations.
Review and approve complaints, non‑conformances, and change‑control documentation.
Prepare quality reports, KPIs, and updates for senior management.
Liaise with insurers, legal teams, and international partners as required.
Support Serious Adverse Event investigations.
Responsible Person Duties (Wholesale Distribution)
Ensure full compliance with WDA conditions, GDP guidelines, and applicable legislation.
Oversee authorised activities, documentation accuracy, and quality of records.
Maintain training programmes for distribution staff.
Manage supplier and customer approvals.
Lead product recall operations.
Oversee returns, rejected/falsified product investigations, and final product disposition.
Ensure self‑inspections are completed and corrective measures implemented.
Manage all HPRA inspections and licence variation applications.
Auditing
Lead the internal audit programme and manage audit resources.
Prepare audit checklists, schedules, and notifications.
Report, track and trend audit findings.
Documentation & Compliance
Manage controlled documentation and SOP implementation.
Ensure timely review and publication of procedures.
Maintain QMS registers and compliance documentation.
Day‑to‑day management of the Quality team, including performance reviews and training.
Motivate, support, and develop team members.
Manage annual leave and resource allocation.
Training & Organisational Development
Ensure all staff complete mandatory and role‑specific training.
Maintain training files and records on relevant systems.
Coordinate training workshops related to EU Tissue and Cell Directive requirements.
Lead supplier evaluation and maintain effective supplier relationships.
Chair supplier review meetings and ensure organisation requirements are met.
Qualifications
Degree in quality, science, or related field.
Responsible Person (RP) certification.
Minimum 3 years’ experience in a supervisory or management role in GDP Quality environment.
Strong leadership, communication, and people management skills.
High attention to detail and commitment to accuracy.
Experience in Good Distribution Practice (GDP).
Experience in the healthcare or pharmaceutical sector.
Integrity, accountability, and strong personal leadership.
Collaborative, team‑focused mindset.
Excellent communication and conflict‑management skills.
Commitment to continuous improvement.
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
Industries: Hospitals and Health Care; Health and Human Services
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