Quality Leader & Responsible Person - GDP Compliance

Primeline Group; Ashbourne; Remote; EUR 60,000 - 90,000; Full time

Job summary

Primeline Group seeks a Quality Manager & Responsible Person to lead GDP compliance across our Ashbourne warehouse and distribution operations. You will maintain the QMS, oversee audits, manage CAPA, and act as RP for WDAs, ensuring regulatory alignment and continuous improvement.

Key collaboration with operations, customers, and regulatory bodies to sustain quality, safety and product integrity, while supporting business growth and customer excellence.

Qualifications

• Eligible to act as a Responsible Person under Irish Wholesale Distribution Authorisation requirements.
• Experience in a GDP-regulated pharmaceutical, healthcare or related environment.
• Experience managing or supporting regulatory, certification and customer audits.
• Strong understanding of Quality Management Systems (QMS).
• CAPA processes and regulatory compliance frameworks.
• Strong communication, organisational and stakeholder management skills.

Responsibilities

• Act as the named Responsible Person on two Wholesale Distribution Authorisations (WDAs).
• Ensure ongoing compliance with GDP and relevant regulatory requirements.
• Lead the resolution and close-out of findings arising from HPRA inspections.
• Develop, review and approve SOPs, deviations and change controls.
• Conduct quality and compliance risk assessments.
• Deliver GDP training and promote a strong quality culture across the business.
• Plan and manage mock recalls, temperature mapping exercises and transport validation activities.
• Complete bona fide checks of principals and wholesale customers.
• Conduct self-inspections and manage returns decisions.
• Oversee the Falsified Medicines Directive (FMD) system.
• Audit service providers and transport subcontractors and maintain technical agreements.
• Review temperature monitoring records and alarm testing activities.

Skills

RP eligibility

GDP knowledge

QMS understanding

Audit management

Stakeholder mgmt

Education

Science/Pharma degree

Job description

Primeline Group seeks a Quality Manager & Responsible Person to lead GDP compliance across our Ashbourne warehouse and distribution operations. You will maintain the QMS, oversee audits, manage CAPA, and act as RP for WDAs, ensuring regulatory alignment and continuous improvement.

Key collaboration with operations, customers, and regulatory bodies to sustain quality, safety and product integrity, while supporting business growth and customer excellence.