Clinical Quality Specialist - QMS & MIA (Employed or freelance)

About this role

📋 Tasks and responsibilities As Quality Specialist - Clinical QP, you will evaluate and reinforce the quality management system in line with applicable EU GMP requirements. The role contributes to inspection readiness and supports the Manufacturing Import Authorization project by identifying gaps, defining corrective actions, and enabling compliant processes for certification of clinical products. Major responsibilities Review and assess the existing quality management system, including policies, SOPs and quality records.

Evaluate alignment with applicable EU GMP requirements, including requirements relevant to clinical trial manufacturing and importation. Identify regulatory, procedural and implementation gaps, and define risk-based remediation priorities. Take a leading role in the Manufacturing Import Authorization (MIA) project as the quality subject matter expert. Support preparation for Health Authority inspections linked to the MIA application.

Ensure inspection readiness of key quality systems such as document control, training, deviation management, CAPA, change control, supplier oversight and batch documentation. Help align processes and procedures to enable QP certification and release management for clinical products. Work closely with QA Operations, Qualified Person, Regulatory, Manufacturing and other relevant stakeholders. Provide clear, pragmatic and inspection-focused recommendations to facilitate timely decisions.

📝 Your profile You bring solid experience in pharmaceutical quality assurance, ideally in a senior QA management environment, with a strong focus on clinical medicinal products. Extensive experience in setting up and strengthening a quality management system. Proven experience with MIA licence application requests. A QP certificate is not mandatory, but it is considered an asset. Strong expertise in audit preparation and inspection readiness.

Strong knowledge of EU GMP requirements applicable to medicinal products and investigational medicinal products. Sound understanding of the EU clinical trial regulatory framework, including Regulation (EU) No 536/2014 and EudraLex Volume 10 guidance. Detailed knowledge of Manufacturing and Import Authorization requirements for importing medicinal products and investigational medicinal products into the EU/EEA. Good understanding of EU GMP Annex 21 regarding the importation of medicinal products.