Senior Qualified Person (QP) & Responsible Person (RP)

Qualified Person (QP) & Responsible Person (RP) - Combined Role

Location: Leiden, Netherlands

Industry: Pharmaceuticals / Biotechnology

Employment Type: Full-time Hybrid

About the Role:

We are supporting a leading pharmaceutical company in the search for a Qualified Person (QP) & Responsible Person (RP) for a single combined position. Based at a strategic satellite office near Leiden, you will be responsible for ensuring full compliance with EU GMP and GDP requirements across the release and distribution of sterile and solid dose products.

This is a senior, high-trust role offering autonomy and cross-functional collaboration, with the opportunity to directly impact patient safety and regulatory excellence across international markets.

Core Responsibilities:

• Act as the named QP and RP on the company's MIA and WDA licenses.
• Certify batches of medicinal products for release, ensuring compliance with GMP, marketing authorisations, and applicable legislation.
• Maintain oversight of wholesale distribution activities, ensuring GDP compliance across all operations.
• Manage deviations, recalls, quality complaints, change controls, and product disposition.
• Approve and oversee third-party service providers, suppliers, and quality agreements.
• Ensure compliance with national legislation, including the Dutch Medicines Act and Opium Act (Opiumwet).
• Serve as the primary point of contact for regulatory inspections and communications with authorities.

Requirements:

• Eligible to act as both QP and RP under EU and Dutch regulations.
• Degree in Pharmacy, Chemistry, or Life Sciences (Pharmacist preferred).
• Fluent in Dutch and English (C1 level minimum).
• At least 2 years' experience in GMP/GDP pharmaceutical environments, including batch release and sterile manufacturing.

What's on Offer:

• Competitive salary and bonus (flexible depending on experience)
• Hybrid working model (minimum 3 days onsite)
• Dynamic, collaborative environment within a global business
• Strategic role with significant regulatory responsibility

If you're a qualified QP and RP ready to take on a pivotal compliance role in a high-growth, global pharma business, we'd love to hear from you.