Quality Specialist
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Our client, a leading life sciences organization, is seeking a specialist to assess and enhance a quality management system in alignment with EU GMP requirements. The role supports inspection readiness and a manufacturing import authorization project to enable compliant processes for clinical product certification.
Responsibilities
- Review and assess the current quality management system, including policies, SOPs, and quality records.
- Evaluate system alignment with applicable EU GMP requirements for clinical trial manufacturing and importation.
- Identify regulatory, procedural, and implementation gaps to define risk-based priorities for remediation.
- Lead the Manufacturing Import Authorization (MIA) project as a quality subject matter expert.
- Support preparation for Health Authority inspections and ensure readiness of critical systems such as deviation management and CAPA.
- Collaborate with stakeholders to align processes for clinical product certification.
Requirements
- You have 8+ years of relevant experience in pharmaceutical quality assurance and quality management.
- You bring extensive expertise in setting up a QMS and managing Manufacturing Import Authorization (MIA) license requests.
- You possess expert knowledge of EU GMP requirements (including Annex 16 and Annex 21) and regulatory frameworks for clinical trials such as Regulation (EU) No 536/2014.
- You have experience managing quality systems including batch documentation, supplier oversight, CAPA, and change control.
- You're a collaborative professional with a pragmatic, inspection-focused approach to problem-solving.
- You are fluent in English.
Nice to Haves
- Possession of a Qualified Person certification.
- Active knowledge of Dutch or French.
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