Responsible Person & Qualified Person – Hybrid Role (Wholesale AH NL)

We are seeking a highly qualified professional to take on a combined Responsible Person (RP) and Qualified Person (QP) position within our organization in the Netherlands. This is a hybrid role with a clear split in responsibilities: ~80% Responsible Person (GDP-focused) and ~20% Qualified Person (GMP-focused). In this role, you will ensure full compliance with Dutch regulatory requirements and European legislation, including oversight by the Dutch Health and Youth Care Inspectorate (IGJ).

Responsibilities

Act as legally appointed Responsible Person in accordance with GDP and Dutch legislation; Ensure medicinal products, APIs, and controlled substances are received, stored, and distributed in GDP compliance; Maintain and improve Quality Management System (QMS) in line with GDP and IGJ expectations; Ensure compliance of activities under Wholesale Distribution Authorisation (WDA); Take final responsibility for disposition of returned/rejected/falsified/recalled products, approval of reintroduction, and oversight of outsourced activities; Ensure qualification of suppliers, customers, and transportation partners; Handle complaints and deviations; Execute self-inspections and CAPAs; Act as primary contact for GDP-related IGJ inspections; Ensure compliance with Dutch Opium Act; Coordinate product recalls; Ensure training programs implemented; Act as Qualified Person under EU Directive 2001/83/EC; Certify and release medicinal product batches in compliance with EU GMP (Annex 16 and 21); Maintain oversight of GMP-compliant processes; Support/lead GMP inspections and audits; Review/approve batch documentation, deviations, investigations, CAPAs, and Product Quality Reviews; Ensure GMP documentation is compliant; Assess/approve suppliers and contractors from GMP perspective; Act as escalation point for GMP compliance risks

Requirements

Demonstrated experience in GDP; Demonstrated experience in GMP; Proven experience working with or under supervision of IGJ; Strong knowledge of EU pharmaceutical legislation; Strong knowledge of Dutch regulatory framework (including Opiumwet, WDA); Experience with regulatory inspections and audits; Eligible to act as Responsible Person (RP) under GDP; Eligible to act as Qualified Person (QP) under Directive 2001/83/EC; University degree in Pharmacy, Chemistry, Biology, or related life sciences discipline