GDP-Driven Quality Manager & Responsible Person

Primeline-5; Ashbourne; On-site; EUR 80,000 - 120,000; Full time

Job summary

Primeline-5 is seeking a Quality Manager & Responsible Person to own quality and regulatory compliance across warehousing. You will manage the Quality Management System, ensure GDP compliance, and act as the named RP for WDAs, while collaborating with auditors and operations teams.

The role requires leading CAPA, audits, training, and continuous improvement initiatives to support growth, customer excellence, and regulatory adherence within a fast-paced distribution environment.

Qualifications

• Eligible to act as RP under Irish WDA requirements.
• Experience in GDP-regulated pharmaceutical or healthcare environments.
• Experience supporting regulatory, certification and customer audits.
• Familiar with FMD/IMVO requirements and audit processes.

Responsibilities

• Act as named RP on Wholesale Distribution Authorisations and ensure GDP compliance.
• Maintain the Quality Management System and approve SOPs and changes.
• Lead CAPA, audits, and continuous improvement across warehousing operations.
• Deliver GDP training and promote a strong quality culture.
• Plan mock recalls, transport validation, and temperature monitoring activities.
• Review findings, close out HPRA issues, and manage supplier audits.

Skills

Quality management

Regulatory compliance

Stakeholder management

Auditing

GDP knowledge

Education

Science or Pharmacy degree

Job description

Primeline-5 is seeking a Quality Manager & Responsible Person to own quality and regulatory compliance across warehousing. You will manage the Quality Management System, ensure GDP compliance, and act as the named RP for WDAs, while collaborating with auditors and operations teams.

The role requires leading CAPA, audits, training, and continuous improvement initiatives to support growth, customer excellence, and regulatory adherence within a fast-paced distribution environment.