Quality Assurance Manager – Healthcare Distribution (GDP/RP)

About the role

We are seeking an experienced Quality Assurance Manager to lead our Good Distribution Practice (GDP) programme and act as the Responsible Person (RP) for a fast‑growing healthcare distributor serving hospital pharmacies across Ireland. The role ensures regulatory compliance, oversees the quality system and drives continuous improvement in a temperature‑controlled environment.

Key responsibilities

• Maintain and oversee the Quality Management System in line with HPRA, EU GDP and Wholesale Distribution Authorisation (WDA) requirements.
• Manage RP obligations, including liaison with the HPRA, notification of changes and upkeep of licences, authorisations and certificates.
• Control bona fides, ensuring annual verification of wholesale/manufacturing authorisations and GMP/GDP certificates.
• Lead training and competence programmes for all staff handling medicinal products, recording and reviewing training records.
• Supervise premises suitability, temperature monitoring, non‑conformance handling, CAPA, complaints and audit close‑outs.
• Identify and implement process improvement opportunities and conduct independent verification checks.
• Maintain documentation for product quality impact, controlled drugs, change control, deviation/CAPA management and quality reviews.

Required profile

• Minimum 8 years senior QA experience in a regulated distribution and logistics environment.
• Proven experience in an HPRA/EU GDP‑regulated organisation.
• Strong knowledge of temperature‑controlled activities and global regulatory requirements for medicinal product wholesaling.
• Demonstrated ability to act as Responsible Person and manage regulatory liaison with health authorities.

Required skills

• Good Distribution Practice (GDP) implementation and compliance.
• HPRA guidelines and EU GDP regulations.
• Temperature monitoring and control systems.
• CAPA and deviation management.
• Document control and change management.
• Regulatory liaison and audit handling.