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

📋 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.
• Detailed knowledge of EU GMP Annex 16 principles for Qualified Person certification and batch release.
• Understanding of regulatory expectations for investigational medicinal products, including manufacturing, importation, testing, labelling, storage, transport, release documentation and traceability.
• Ability to interpret and apply EU and Belgian regulatory requirements within a pharmaceutical quality system, and translate them into procedures, quality agreements, batch certification processes, inspection readiness plans and risk-based remediation actions.
• Strong knowledge of batch documentation expectations for clinical products, including batch manufacturing records, analytical results, deviations, OOS/OOT investigations, change controls, temperature records, transport records, import documentation, certificates of analysis and QP release evidence.
• Understanding of supplier oversight and outsourced activities, including manufacturing, testing, storage, transport, supplier qualification and quality agreements.
• Ability to assess gaps in procedures, systems and records against EU GMP, clinical trial, importation and QP certification requirements.
• Strong capabilities in quality management, release management and QMS setup.
• You communicate professionally in Dutch or French, with a good command of English.

💼 Offer

You will be part of a growing Belgian SME where initiative and personal development are encouraged. We will provide you with an enjoyable work environment with fun colleagues. We will work out a career plan with you, with attention and a budget for extra education/certification. You can count on an attractive salary, supplemented with extra-legal benefits, including a company car.
(Freelance is also possible)