Quality Compliance Lead, GDP/GMP (Pharma)

Hollybank Trustees Ltd; Leinster; On-site; EUR 95,000 - 120,000; Full time

Job summary

PHX Ireland seeks an experienced quality leadership professional to oversee GDP compliance and HPRA-aligned GMP processes within the Quality Management System. The role supports Responsible Persons, maintains inspection readiness, and drives CAPA, change control and supplier qualification across PHX Ireland sites.

Five years in a pharma-quality leadership role is required, with strong HPRA GDP knowledge and GMP understanding.

Qualifications

• Minimum of five years’ experience in a team leader or management role in pharmaceutical quality, wholesale distribution, manufacturing, logistics or regulated healthcare.

Responsibilities

• Provide quality compliance leadership for GDP and applicable GMP system processes within the Quality Management System.
• Support Responsible Person and Deputy Responsible Persons to maintain compliance with HPRA GDP expectations.
• Oversee Wholesale Distribution Authorisation requirements and site operations to HPRA GDP expectations and licencing scope.
• Maintain inspection readiness with up-to-date records, procedures and training for regulatory inspection.
• Manage deviation, investigation and CAPA processes with root cause analysis and effective corrective actions.
• Oversee change control activities including regulatory/GDP impact assessment and closure.
• Maintain and improve document control ensuring procedures and records are controlled and aligned with regulatory needs.
• Lead or support internal audits and self-inspection across sites and quality systems.
• Manage supplier/customer qualification processes including bona fides checks and vendor approvals.
• Ensure quality oversight of storage, temperature control, cold chain, transport, returns and destruction processes.
• Support qualification and monitoring of storage/transport conditions to protect product quality.
• Maintain training management for GDP and GMP activities including training effectiveness.

Skills

Team leadership

HPRA GDP knowledge

EU GDP guidelines

Quality Management System

GMP principles

Regulatory compliance

Job description

PHX Ireland seeks an experienced quality leadership professional to oversee GDP compliance and HPRA-aligned GMP processes within the Quality Management System. The role supports Responsible Persons, maintains inspection readiness, and drives CAPA, change control and supplier qualification across PHX Ireland sites.

Five years in a pharma-quality leadership role is required, with strong HPRA GDP knowledge and GMP understanding.