Description

With 12+ years of experience in pharma sterile vaccines manufacturing, I support manufacturers in building robust, inspection-ready quality systems, without compromising operational efficiency.

I specialize in sterile environments, validation strategy, and contamination control, with strong expertise in Annex 1 implementation and the mindset shift it requires. My approach goes beyond compliance: I help teams embed risk-based thinking into daily operations.

Working at the intersection of science, GMP regulations, and manufacturing reality, I translate complex requirements (EU GMP, 21 CFR, ISO standards) into pragmatic, sustainable solutions that stand up to audits and to real-life constraints.

Langues

Français
Bilingue ou natif
Anglais
Capacité professionnelle complète
Néerlandais
Capacité professionnelle limitée
Italien
Notions

Préférences en matière de lieu de travail

Accepte de travailler sur site

Namur (jusqu’à 50 km)

GSK GSA
External Quality Lead
INDUSTRIE PHARMACEUTIQUE
janvier 2024 - janvier 2025 (1 an)
Wavre, Belgique
• Quality oversight and compliance during technical transfers between CMOs and GSK sites.
• Work in cross-functional teams with effective stakeholder management, fostering collaboration and clear communication with CMOs and internal teams
• Focused on mitigating risks, enhancing compliance, and supporting business growth through robust quality management in technical transfers
• Leading quality governance for transfer projects, ensuring timely issue resolution (DMAIC approach) and action completion.
• Developing and managing Quality Agreements and providing strategic quality input during regulatory inspections.
GSK GSA
QA External Supply Manager
INDUSTRIE PHARMACEUTIQUE
février 2021 - septembre 2024 (3 ans et 7 mois)
Wavre, Belgique
• Be the quality contact point for a CMO performing formulation, filling and visual inspection
• Ensure accountability for all quality activities linked to the CMO management (deviations, CAPA closure, risks management, release, complaints, product quality review, …)
• Ensure that Quality systems are in place/in use, routinely monitored and assessed
• Annex 1 gap assessment, USP compliance including new USP 665…
• Master quality agreement content and be accountable to fulfill the requirements
GSK GSA
Sterility Assurance Specialist
INDUSTRIE PHARMACEUTIQUE
février 2017 - mars 2021 (4 ans et 1 mois)
Wavre, Belgique
• Perform risk assessment analysis (FMEA, environmental monitoring risk assessment), risk based decision making
• Continuous improvement by using lean principles (Gemba, Poka-Yoke, PDCA, 5S…)
• Develop sterility assurance competences of supervisors and operators
• Investigation and quality decision on sterility assurance issues
• Problem solving and root cause analysis (Gemba, 6M, 5 Whys…)
• Prepare and manage internal and external cGMPs and EHS audits
• Review and approbation of SOPs, review of media simulations, assessment of sterility assurance impacts in change controls, Contamination Control Strategy author