Responsible Person (NL WDA) - Freelancer

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.