Key Skills

Job Description

Key facts: Engagement type: Freelance / contract, part-time Location: Netherlands (remote with on-site presence required for inspection preparation and inspection day) Duration: ~9 months, start mid-November to early December 2026 Effort: ~45 days total, averaging ~5 days/month (~25% FTE), with peaks of 8–10 days around entity setup and around the inspection Extension: Option to continue as RP on a ~2 days/month retainer once the licence is granted Experience: Previous experience acting as RP on an EU wholesale license, ideally a Dutch one. Experience adapting a eQMS solution, ideally for a “virtual” wholesaler that outsources storage and shipping. Experience with IGJ inspections, or other EU inspections. Familiarity with export to the US and with outsourced partners such as CMOs and 3PLs. Regulatory eligibility: Meets the EU GDP Guidelines (2013/C 343/01, chapter 2.2) requirements for an RP: competence, experience, GDP knowledge and training. Accepted by Farmatec/IGJ to be named as RP on the wholesale license. Permanently and continuously available to the license holder. If contracted rather than employed, this must be guaranteed in the contract, with a named backup RP. Responsibilities: Setting up the QMS Adapt customer’s existing eQMS to cover the Dutch entity and EU GDP. Write or adapt GDP procedures: supplier and customer qualification, change control, deviations, CAPA, complaints, returns, recalls, falsified medicines, self-inspection, training and management review. Prepare the wholesale license application with Farmatec and get ready for the IGJ inspection. Ongoing RP duties Ensure GDP compliance of the NL entity and all outsourced activities. Qualify and audit the 3PL and transport providers, and maintain quality agreements with them. Approve suppliers and customers, and confirm US consignees are legitimate. Handle deviations, complaints, returns and recalls. Act as the main contact for IGJ and Farmatec. Report to customer’s management on GDP compliance and risks. Skills: Strong knowledge of EU GDP, Dutch Geneesmiddelenwet requirements and the basics of EU GMP. Working knowledge of US requirements (FDA, DSCSA) is an advantage, since the entity exports to the US. Fluent in English. Dutch is a strong advantage for dealing with the authorities.

Core Responsibilities

Set up and adapt the Dutch entity’s eQMS and GDP procedures, prepare the wholesale license application, and support readiness for the IGJ inspection. Serve as the Responsible Person by overseeing GDP compliance, outsourced providers, quality processes, regulatory communications, and reporting compliance risks to management.

Requirements

Candidates need prior experience as a Responsible Person on an EU wholesale license, strong EU GDP knowledge, and eligibility and availability to be named as the license holder’s RP. Experience with eQMS implementation, inspections, outsourced logistics and manufacturing partners, and US export requirements is valuable; fluent English is required and Dutch is a strong advantage.