Quality Specialist - Clinical QP

Arcadis; Oost-Vlaanderen; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Arcadis is seeking a quality specialist – Clinical QP to strengthen the Quality Management System in line with EU GMP for clinical products. The role supports MIA readiness and regulatory interactions, identifying gaps and enabling compliant processes for certification.

You will work with QA Operations, Regulatory, Manufacturing, and other stakeholders to ensure inspection readiness, proper documentation, and timely decisions through pragmatic recommendations.

Qualifications

• Experience setting up a QMS.
• Experience with requesting MIA license.
• QP certificate not mandatory but preferred for license experience.
• Strong knowledge of EU GMP for medicinal products and IMPs.
• Knowledge of Regulation (EU) 536/2014 and EudraLex Volume 10 guidance.
• Knowledge of MIA requirements for importation of medicinal products/IMPs into EU/EEA.
• Understanding EU GMP Annex 21 (importation) and Annex 16 (QP certification).
• Ability to interpret EU and Belgian regulatory requirements into procedures and risk remediation actions.
• Knowledge of batch documentation and OOS/OOT investigations.
• Experience with supplier and third-party oversight in importation and certification supply chain.
• Ability to assess gaps against EU GMP, clinical trial, importation, QP requirements.

Responsabilités

• Review and assess the current QMS, including policies, SOPs, and quality records
• Evaluate QMS alignment with EU GMP requirements for clinical trial manufacturing/importation
• Identify gaps and 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 related to the MIA
• Ensure inspection readiness of critical quality systems such as document control, training, deviation management, CAPA, change control, supplier oversight, and batch documentation
• Support alignment of processes for QP certification of clinical products
• Collaborate with QA Operations, Qualified Person, Regulatory, Manufacturing, and other stakeholders
• Provide clear, pragmatic, and inspection-focused recommendations for timely decision-making

Connaissances

Quality Assurance Manager

GMP Knowledge

Release Management

QMS Setup

License Requesting

Clinical Medicinal Products

English Proficiency

Dutch or French (nice to have)

Description du poste

This role as quality specialist – Clinical QP needs to assess and strengthen the Quality Management System in alignment with applicable EU GMP requirements. The function supports inspection readiness and the Manufacturing Import Authorization project by identifying gaps, defining actins, and enabling compliant processes for clinical product certification.

Major responsibilities

• Review and assess the current QMS, including policies, SOPs, and quality records
• Evaluate QMS alignment with applicable EU GMP requirements, including those relevant for clinical trial manufacturing/importation
• Identify regulatory, procedural, and implementation gaps and define risk‑based priorities for remediation
• Actively lead the Manufacturing Import Authorization (MIA) project as a quality subject matter expert
• Support preparation for Health Authority inspections related to the MIA application
• Ensure inspection readiness of critical quality systems such as document control, training, deviation management, CAPA, change control, supplier oversight, and batch documentation
• Support alignment of processes and procedures to enable QP certification of clinical products
• Collaborate closely with QA Operations, Qualified Person, Regulatory, Manufacturing, and other key stakeholders
• Provide clear, pragmatic, and inspection‑focused recommendations to support timely decision‑making

Required Knowledge and skills

• Extensive experience in setting up a QMS
• Experience with requesting MIA license
• A QP certificate is not mandatory for this position, but could be preferrable as this person may bring the necessary license requesting experience
• Strong knowledge of EU GMP requirements applicable to medicinal products and investigational medicinal products, including the principles of the Pharmaceutical Quality System, documentation, production, quality control, outsourced activities, deviations, CAPA, change control, complaints, recalls, self-inspection and inspection readiness
• Sound understanding of the regulatory framework for clinical trials in the EU, including Regulation (EU) No 536/2014 and associated EudraLex Volume 10 guidance for clinical trial applications, sponsor responsibilities, and manufacturing/importation of investigational medicinal products
• Detailed knowledge of Manufacturing and Import Authorization (MIA) requirements for the importation of medicinal products and investigational medicinal products into the EU/EEA
• Good understanding of EU GMP Annex 21 on importation of medicinal products, including the distinction between physical importation, customs clearance, site of physical importation, site of QP certification
• Detailed knowledge of EU GMP Annex 16 principles for Qualified Person certification and batch release
• Understanding of the specific regulatory expectations for investigational medicinal products, including appropriate control of manufacturing, importation, testing, labelling, storage, transport, release documentation, and traceability prior to clinical use
• Ability to interpret and apply EU and Belgian regulatory requirements in a pharmaceutical quality system, including translating regulatory expectations 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 and third‑party oversight expectations, including outsourced manufacturing, testing, storage, transport, quality agreements, supplier qualification, and the need to maintain adequate oversight across the importation and certification supply chain
• Ability to assess gaps in procedures, systems, and records against EU GMP, clinical trial, importation, and QP certification requirements

Skills

• Previous experience as a Quality Assurance Manager is required
• Strong knowledge of GMP, Quality Management and Release Management
• Advanced knowledge of Clinical Medicinal Products
• Expert experience with the set up of QMS, License requesting and auditing
• Full professional proficiency in English, knowledge of Dutch or French is a nice to have