Freelance/Contract - Responsible Person (RP) & Quality Manager - Consultant

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

Position Overview

ProPharma is currently supporting an international pharmaceutical group requiring support for their GDP QA activities within the Netherlands and Belgium. This project is to be the acting Responsible Person and Quality Manager for the region; it will ideally commence in March and will run for at least 3-6 months while our client appoints a permanent individual. The role can be performed largely remotely; it requires 3 days a week support throughout and requires demonstrated skills working as a Responsible Person in the Netherlands or Belgium.

In this position, you will act as the Responsible Person/Quality Manager to help ensure all regulations are met to continue to distribute our client’s products within the region. In addition, you will maintain an overview of the supply chain activities; review and approve change requests, deviation reports, CAPA’s as well as liaising with Regulatory authorities. You will also have the opportunity to provide strategic advice, support QA activities in general, support Technical Operations teams, and prepare for any Healthcare authority inspections.

Qualifications

• A University degree in Science/Engineering is required, preferably MSc in Pharmacy or similar.
• Must be able to demonstrate thorough experience working as a Responsible Person within the Netherlands or Belgium (current experience would be highly preferred).
• Thorough experience working in Quality Assurance with extensive skills working within GDP QA.
• Fluency in English and Dutch (or French) would be required.
• Currently based in the Netherlands or Belgium.
• Can perform the project to the required needs within the job description.