RP

Walker Cole International is supporting an Ireland-based life sciences organisation specialising in the distribution of sterile medicinal products in the appointment of a Responsible Person (RP). This role will provide leadership and oversight of GDP compliance while supporting ongoing distribution and supply chain activities within a highly regulated environment.

This position will play a critical role in maintaining and strengthening the organisation’s Quality Management System (QMS), ensuring compliance with EU GDP requirements, and acting as a key point of contact with regulatory authorities. The successful candidate will provide hands-on RP support across distribution activities, quality systems, and cross-functional teams.

Key Responsibilities

• Act as the Responsible Person (RP) named on the Wholesale Distribution Authorisation (WDA)
• Ensure compliance with EU GDP and applicable regulatory requirements
• Maintain oversight of the storage and distribution of sterile medicinal products
• Ensure the organisation maintains a continuous state of inspection readiness
• Act as the primary quality representative during regulatory inspections (e.g. HPRA)
• Provide RP oversight of:
  • Deviations and investigations
  • CAPA
  • Change control
  • Complaints and recalls
  • Returns and falsified medicines processes
  • Document and record management
• Ensure appropriate oversight of temperature-controlled logistics, transportation and warehousing partners
• Support ongoing development and improvement of the Quality Management System (QMS)
• Oversee supplier qualification, third-party management and Quality Technical Agreements
• Collaborate with Quality, Regulatory Affairs, Supply Chain and Operations to ensure compliant and efficient distribution activities
• Provide expert guidance on GDP requirements, cold-chain distribution and governance
• Promote a strong quality and compliance culture across the organisation

Required Experience and Skills

• Eligible to act as a Responsible Person (RP) under EU GDP
• Proven experience operating on a Wholesale Distribution Authorisation (WDA)
• Strong working knowledge of EU GDP and wider GxP regulations
• Experience working with regulatory authorities including the HPRA
• Demonstrable experience overseeing distribution of sterile or temperature-sensitive medicinal products
• Strong expertise in QMS processes including deviations, CAPA, change control and supplier management
• Experience supporting and hosting GDP inspections
• Strong understanding of cold chain distribution and supply chain risk management
• Excellent stakeholder engagement and communication skills
• Able to operate effectively in a hands-on contract role

Working Pattern

On-site (Ireland)

Contract Length

6 months

Rate

Day rate negotiable depending on experience

Location

Ireland

Keywords

Responsible Person | RP | GDP | WDA | Sterile Products | Cold Chain | Distribution | Pharmaceutical | Contract | Regulatory Compliance