Quality Manager

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

Are you an experienced Quality professional with the expertise to act as a Responsible Person (RP) under Irish WDA requirements?

We're looking for a Quality Manager & Responsible Person to take ownership of our quality and regulatory compliance activities, ensuring the highest standards across our warehousing and distribution operations. This is a key leadership role offering the opportunity to influence business performance, drive continuous improvement, and act as the organisation's primary quality and GDP compliance expert

The Role

As Quality Manager & Responsible Person, you will be responsible for maintaining our Quality Management System, ensuring compliance with GDP regulations, and acting as the named RP across our Wholesale Distribution Authorisations.

You will work closely with operational teams, customers, auditors, and regulatory bodies to ensure quality and compliance standards are maintained while supporting business growth and customer excellence.

Key Responsibilities

Responsible Person (RP)

• 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.

Quality Management

• Lead customer audit programmes and oversee CAPA implementation and closure.
• Host regulatory, customer and certification audits.
• Manage BRCGS, ISO and AIB audit requirements.
• Coordinate mock audits, hygiene inspections and facility audits.
• Investigate and manage customer complaints and quality issues.
• Continuously improve the Quality Management System to meet evolving business and regulatory requirements.
• Support new customer onboarding and warehouse quality set-up activities.
• Lead traceability exercises and product integrity initiatives.
• Oversee pest control programmes.
• Support Health & Safety activities, training and compliance initiatives.

About You

• Eligible to act as a Responsible Person under Irish Wholesale Distribution Authorisation requirements.
• Experience working within 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
• Regulatory compliance frameworks
• Strong communication, organisational and stakeholder management skills.
• Experience with BRCGS Storage & Distribution, ISO and AIB standards.
• Experience within a logistics, warehousing or supply chain environment.
• Degree or equivalent qualification in Science, Pharmacy, Environmental Health, Food Safety or a related discipline.
• Familiarity with FMD / IMVO requirements.
• Food Safety and Health & Safety knowledge.

Why Join Us?

This is an excellent opportunity to join a growing organisation where quality, compliance and continuous improvement are central to our success. You'll have the autonomy to drive standards, influence strategic decisions and make a tangible impact across the business while working alongside a committed and collaborative team.

Ready to take the next step in your Quality career? We'd love to hear from you.