Freelancer profile translated to English.
Back to original languageAbout Stefaan
• Experienced senior professional in various quality assurance, pharmacovigilance, project management, and contract and budget management areas, bringing a global, integrated, cross-functional, and interdisciplinary project perspective focused on quality.
• Quality-oriented, ethical, autonomous, and adaptable mindset, capable of working in teams and independently, under pressure, in a regulated, complex, and constantly evolving, fast-paced environment.
• Interested in leading, supporting, and overseeing operational quality and project activities, exploring new areas, analyzing, evaluating, implementing new processes, systems, seeking continuous process improvements, or developing projects in various cross-functional areas with multidisciplinary, multilingual, and multicultural teams.
• Excellent project management skills, significant learning and adaptation capabilities, including in unstructured or to-be-structured environments, and intellectual curiosity, useful for facilitating interdepartmental, cross-functional, transversal, and multidisciplinary interactions for projects based on a risk assessment approach, with stakeholders from different technical fields, cultures, and locations.
• Ability to learn, understand, and use different technical languages, manage constraints, priorities, regulatory requirements, and stakeholder expectations, anticipate potential stakeholder concerns, project obstacles, and problems, and propose solutions.
Affinity with process and quality aspects, trained in ISO 9001 (Quality), 19011 (Audit), 14001 (Environment), and 45001 (Occupational Health and Safety) standards.
• Calm, composed, attentive personality, bringing good humor, wit, and enthusiasm to a group or team.
French
Native or bilingual
English
Fluent
Dutch
Fluent
Italian
Fluent
Can work on-site
Bruxelles (up to 50km)
Experience
- KalicoopClinical Research Quality and Pharmacovigilance ConsultantMay 2025 - Today (1 year and 3 months)• Pharmacovigilance Affiliate Consultant assignment, Safety department: Supports oversight of local PV compliance, readiness for inspections, contact point for safety-related aspects internally and externally. Contributes to quality operational execution of safety-related activities, collaborating with Pharmacovigilance Hubs.
- EORTC - European Organisation for Research and Treatment of CancerScientific Auditor and Risk ManagerSeptember 2023 - March 2025 (1 year and 6 months)Brussels, Belgium• Conducted internal, supplier audits, and supported third-party assessments as part of the organization's audit program.• Oversaw CAPA follow-up and audit documentation in alignment with internal quality standards.• Provided risk management support to the Audit and Financial Committee, on operational, strategic, and compliance-related risks.
- Business Competence Center Gosselies / Analis SAQuality Systems & Compliance Analyst (ISO Standards Focus)June 2022 - August 2023 (1 year and 2 months)Gosselies, HT, Belgium• Completed formal training in ISO 9001 (Quality), ISO 14001 (Environmental), ISO 45001 (Occupational Health & Safety), ISO 13485 (Medical Devices), and ISO 19011 (Audit Management Systems).• Applied knowledge during a quality support project at Analis SA, contributing to ISO 9001 certification readiness through review of supplier selection and evaluation processes.
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Education
- QSE Quality SpecialistBusiness Competence Center Gosselies2022Standards ISO (QSE) Systèmes de management de la Qualité (9001), de la Protection de la Santé et Sécurité au travail (45001) et de l’Environnement (14001). * Identification et compréhension des exigences des normes ISO 9001, 14001 et 45001 (version 2015), * Mise en œuvre pratique des systèmes de management de la Qualité, Santé & Sécurité au travail et Environnement, * Pratique de l’audit interne, * Pilotage des conformités légales, des différentes analyses des opportunités et risques, * Vue d’ensemble sur des outils d’amélioration, * Pratiques de certains outils utiles pour l’amélioration continue dans l’entreprise (5S, Ishikawa, AMDEC, VSM, outils de performance …) * Communication de groupe * Certification VCA (pour cades superviseurs)
Certifications
- Data ProtectionData Protection Institute2022