Quality Manager & Responsible Person - GDP Compliance Leader

Primeline Group; Ashbourne; On-site; EUR 65,000 - 90,000; Full time

Job summary

Primeline Group in Ireland seeks an experienced Quality Manager & Responsible Person to own quality and regulatory compliance across warehousing and distribution operations. You will maintain the QMS, ensure GDP compliance and serve as the named RP across WDAs, collaborating with auditors, customers and regulators to uphold top standards.

You will lead CAPA, audits, supplier governance and training, driving continuous improvement and a strong quality culture across the business.

Qualifications

• Eligible to act as a Responsible Person under Irish Wholesale Distribution Authorisation requirements.
• Experience in GDP-regulated pharmaceutical, healthcare or related environment.
• Experience managing 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.
• Experience with BRCGS Storage & Distribution, ISO and AIB standards.
• Experience in logistics, warehousing or supply chain.
• Degree or equivalent in Science, Pharmacy, Environmental Health, Food Safety or related discipline.
• Familiarity with FMD / IMVO requirements.
• Food Safety and Health & Safety knowledge.

Responsibilities

• Act as the named RP on two WDAs.
• Ensure GDP compliance and regulatory requirements.
• Lead resolution of HPRA inspection findings.
• Develop, review and approve SOPs, deviations and change controls.
• Conduct quality and compliance risk assessments.
• Deliver GDP training and promote a quality culture.
• Plan mock recalls, temperature mapping and transport validation.
• Conduct supplier and wholesale customer bona fide checks.
• Conduct self-inspections and manage returns decisions.
• Oversee FMD system.
• Audit service providers and transport subcontractors.
• Review temperature monitoring records and alarm testing.

Skills

GDP compliance

QMS knowledge

Regulatory audits

CAPA processes

Stakeholder management

SOPs & deviations

Education

Science/Pharmacy degree

Job description

Primeline Group in Ireland seeks an experienced Quality Manager & Responsible Person to own quality and regulatory compliance across warehousing and distribution operations. You will maintain the QMS, ensure GDP compliance and serve as the named RP across WDAs, collaborating with auditors, customers and regulators to uphold top standards.

You will lead CAPA, audits, supplier governance and training, driving continuous improvement and a strong quality culture across the business.