We are seeking an experienced
Responsible Person (RP)
to oversee GDP-compliant wholesale distribution activities for a leading pharmaceutical organisation located in east county Galway.
The RP will act as the primary accountable person under the company's Wholesale Distribution Authorisation (WDA), responsible for the integrity, quality, safety, storage, distribution, recall and documentation of medicinal products.
Key Responsibilities:
Quality & Compliance
* Implement, maintain, and continuously improve the company's Quality Management System (QMS) in line with EU GDP, national regulations, and WDA obligations.
* Ensure that all storage, handling, transport, and distribution activities fully meet GDP standards, safeguarding product quality and traceability.
* Conduct and/or oversee regular self-inspections and internal audits; host regulatory inspections; manage deviations, investigations, CAPAs, and root-cause analyses.
Regulatory Responsibility
* Serve as the main point of contact for regulatory authorities (e.g., HPRA or equivalent) regarding WDA compliance, inspections, product recalls, and regulatory updates.
* Approve and manage supplier and customer bona fide checks as required under GDP.
* Approve and oversee subcontractors and third-party service providers involved in GDP-related activities.
Operational Oversight
* Review and approve all relevant documentation: SOPs, distribution records, traceability logs, returns, rejected/recalled/falsified products, and complaints.
* Make final decisions on product disposition, including approval for returns to stock or compliant disposal.
* Maintain accurate and up-to-date WDA records including audits, inspections, distribution logs, supplier/customer evaluations, and recall documentation.
* Oversee training and competency development for all staff involved in storage, distribution, and quality-related activities.
Compliance & Continuous Improvement
* Monitor changes to relevant legislation and ensure ongoing compliance with GDP, falsified medicines requirements, transport conditions, and applicable import/export regulations.
Qualifications & Experience:
* Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline (or equivalent experience).
* Minimum of 5 years' experience in a quality, distribution, or pharmaceutical environment with strong EU GDP/GMP knowledge.
* Previous experience acting as an RP on a WDA in Ireland or a similar jurisdiction is highly desirable.
* Strong understanding of EU GDP guidelines, HPRA/national requirements, and medicinal product distribution regulations.
* Proven experience with QMS, audits, deviations, CAPA processes, and supply-chain traceability.
* Excellent communication, interpersonal, and decision-making skills; able to collaborate effectively with regulatory bodies, senior leadership, and cross-functional teams.
For a confidential conversation about the role please apply for the role or contact Owen Clancy at By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.