Quality Specialist Clinical QP

A pharmaceutical organisation developing and supplying clinical medicinal products is strengthening its Belgian quality management system for a Manufacturing Import Authorization project. This senior Quality Specialist, Clinical QP role combines EU GMP assessment, audit readiness and QMS setup, with responsibility for processes that enable compliant importation and certification of investigational medicinal products.

The mission

The assignment concerns the quality management system for clinical medicinal products and starts with a structured review of policies, SOPs and quality records. You will assess them against EU GMP requirements for medicinal products and investigational medicinal products, including requirements for clinical trial manufacturing and importation. The assessment covers the Pharmaceutical Quality System, document control, training, deviations, CAPA, change control, supplier oversight and batch documentation, producing a risk-based remediation plan for the MIA application, inspection readiness and QP certification of clinical products.

As quality subject matter expert for the Manufacturing Import Authorization project, you will translate European Union and Belgian regulatory requirements into workable procedures, quality agreements, batch certification controls and inspection evidence. You will collaborate with QA Operations, the Qualified Person, Regulatory, Manufacturing and external partners, connecting day-to-day quality decisions to importation and release management. The role requires clear recommendations, strong audit expertise and practical coordination across stakeholders.

Your responsibilities

• Assess the existing QMS, documenting gaps across policies, SOPs and records and linking each finding to a risk-based remediation action.
• Lead the quality workstream for the MIA project, ensuring application evidence and processes address EU GMP importation requirements.
• Prioritise remediation for document control, training, deviations, CAPA, change control, supplier oversight and batch documentation.
• Strengthen release management and batch certification controls so the Qualified Person can rely on complete, traceable evidence for clinical products.
• Prepare teams and critical quality systems for Health Authority inspections, including response materials and inspection-readiness actions.
• Coordinate QA Operations, Regulatory, Manufacturing and external partners to close gaps and deliver clear, practical decisions.

Your profile

Essential skills

• Bring extensive experience setting up and strengthening a pharmaceutical QMS, with judgement to distinguish critical compliance gaps from lower-risk improvements.
• Apply EU GMP guidelines to medicinal and investigational medicinal products, including Pharmaceutical Quality System principles and inspection readiness.
• Demonstrate license request experience for a Manufacturing and Import Authorization, including the distinction between physical importation, customs clearance, site of physical importation and site of QP certification.
• Use EU GMP Annex 16 for Qualified Person certification and batch release, and Annex 21 for importation.
• Interpret the EU clinical-trial framework, including Regulation (EU) No 536/2014 and EudraLex Volume 10, and apply Belgian requirements.
• Evaluate batch manufacturing records, analytical results, OOS/OOT investigations, temperature and transport records, import documentation and QP release evidence.
• Lead GMP audits and Health Authority inspection readiness, while translating requirements into procedures, quality agreements, supplier oversight controls and risk-based remediation actions.
• Communicate pragmatic recommendations across QA, Regulatory, Manufacturing and external stakeholders. A QP certificate is useful but not required.