Quality Manager / Responsible Person (RP)

Job Description Quality Manager / Responsible Person (RP) Location: Dublin, Ireland Contract Type: Permanent ( Hybrid) Salary: 90k - 100k An exciting opportunity for an experienced Quality Manager / Responsible Person (RP) to join a growing biosimilars organisation backed by one of the world's largest healthcare companies. This role will provide GDP quality oversight across a virtual pharmaceutical supply chain, supporting wholesale distribution, logistics providers, manufacturing partners, and suppliers while ensuring full compliance with regulatory requirements. This position offers excellent long-term career progression, including the opportunity to develop into the designated Responsible Person role within a highly experienced quality team supporting both European and US-facing operations. Key Responsibilities Act as Responsible Person (RP) or Deputy Responsible Person (DRP) for wholesale distribution activities. Maintain and continuously improve the GDP Quality Management System (QMS). Ensure compliance with GDP, GMP, WDA requirements, and applicable regulatory standards. Manage quality events including deviations, CAPAs, complaints, change controls, and risk assessments. Oversee temperature-controlled distribution activities and logistics service providers. Support supplier qualification, audits, quality agreements, and ongoing supplier oversight activities. Collaborate with CMOs and manufacturing partners on investigations, compliance activities, and product quality matters. Participate in internal, supplier, customer, and regulatory audits and inspections. Support inspection readiness activities and act as a key quality contact for regulatory authorities where required. Provide quality leadership across distribution, supply chain, and external partner operations. Requirements Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Microbiology, or a related discipline. 8+ years' experience within pharmaceutical Quality Assurance and GDP-regulated environments. Previous Responsible Person (RP) or Deputy Responsible Person (DRP) experience is essential. Experience being named on a Wholesale Distribution Authorisation (WDA) licence is essential. Strong knowledge of EU GDP regulations and pharmaceutical supply chain operations. Experience managing deviations, CAPAs, complaints, change controls, and quality systems. Experience supporting supplier qualification, audits, and third-party oversight activities. Experience working within wholesale distribution, virtual pharmaceutical, or outsourced supply chain environments is highly desirable. GMP manufacturing quality experience and CMO oversight experience would be advantageous. The Next Step for You Should this position be of interest to you, please forward your CV to Andile Sibanda at Next Generation Recruitment or alternatively call +353 1 960 9773 for a confidential discussion. Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Scientific, Technical and Operations (permanent, contract and temporary) positions. Applications are strictly confidential.