Head of Quality Assurance / Responsible Person GDP at FEBELCO (2023-01 – 2026-12)
- Accountable for Quality Governance across seven GDP distribution centres, ensuring sustained compliance with Belgian and European GDP legislation.
- Led the transformation and continuous improvement of the multi-site Quality Management System (QMS), strengthening governance, compliance and operational excellence.
- Directed regulatory remediation programmes following Health Authority inspections, leading CAPA implementation, effectiveness monitoring and inspection readiness activities.
- Developed and executed risk-based internal and external audit programmes, driving continuous improvement and organisational maturity.
- Oversaw qualification, performance monitoring and quality governance of more than 800 suppliers, applying a risk-based approach to supplier management and temperature-controlled distribution.
- Established quality performance indicators (KPIs) and executive management reporting to support strategic decision-making and organisational performance.
- Led cross-functional quality initiatives involving Operations, Supply Chain, Information Technology, Regulatory Affairs and external business partners.
- Directed product recalls, deviation management, investigations and Quality Risk Management activities, ensuring patient safety and regulatory compliance.
Head – Regional Regulatory Submission Lead, EMEA at MSD (2015-01 – 2023-12)
- Led the Regional Regulatory Submissions function across the EMEA region, providing strategic leadership for complex regulatory submission programmes.
- Directed cross-functional teams delivering regulatory initiatives across multiple countries within a global matrix organisation.
- Led the implementation of major regulatory transformation programmes, including Brexit preparedness and the European Clinical Trials Regulation (EU CTR) and CTIS implementation.
- Collaborated with external stakeholders and industry associations, including EFPIA and EuropaBio, EMA and EU Commission to support the implementation of the European Clinical Trials Regulation (EU CTR) and CTIS.
- Invited speaker at international regulatory conferences in Spain and Türkiye, and presenter at a global virtual CTIS conference during the COVID-19 pandemic, sharing expertise on EU CTR and CTIS implementation.
- Established governance frameworks, performance metrics and executive reporting to enhance operational oversight and support strategic decision-making.
- Drove process harmonisation, standardisation and continuous improvement across regional regulatory operations.
- Partnered with senior stakeholders across Regulatory Affairs, Clinical Development, Clinical Operations, Quality, Supply Chain and Information Technology.
- Represented the organisation in global governance forums, international steering committees and cross-functional strategic initiatives.
- Mentored and developed high-performing professionals within a complex virtual international matrix organisation.
Senior Specialist Regulatory Affairs / Deputy Qualified Person at MSD (2014-01 – 2015-12)
- Led the preparation and coordination of initial Marketing Authorisation Applications (MAAs) across cross-functional teams
- Managed Health Authority interactions and coordinated responses throughout assessment procedures
- Coordinated preparation and quality review of CTD dossiers with CMC, non-clinical and clinical subject matter experts
- Supported lifecycle management activities, including variations, renewals and labelling changes
- Ensured regulatory compliance with European pharmaceutical legislation and regulatory requirements
Clinical Project Manager / Deputy Qualified Person at MSD (2011-01 – 2014-12)
- Managed Phase I–IV clinical trials in accordance with ICH-GCP and global regulatory requirements
- Provided Quality oversight as Deputy Qualified Person during GMP inspections and regulatory audits
- Led quality investigations, deviation management and CAPA implementation within Clinical Operations
- Oversaw IMP lifecycle management, including storage, distribution and compliant destruction
- Ensured cold chain compliance and quality oversight across international clinical supply activities
Associate Clinical Project Manager at UCB (2010-01 – 2011-12)
- Supported the management and coordination of complex multi-country clinical programmes across an international study portfolio.
- Worked within global cross-functional study teams to support trial planning, execution, milestone tracking and issue resolution.
- Coordinated activities across internal stakeholders, local teams and external partners within a complex global matrix environment.
- Supported clinical trial delivery in accordance with ICH-GCP, study protocols and applicable regulatory requirements.
Senior Clinical Research Associate at ALLERGAN (2009-01 – 2010-12)
- Managed and monitored clinical trial sites across Belgium and the Netherlands, ensuring compliance with study protocols, ICH-GCP and applicable regulatory requirements.
- Supported clinical studies in Overactive Bladder (OAB) and Benign Prostatic Hyperplasia (BPH).
- Oversaw site performance, patient recruitment, data quality and timely resolution of study-related issues.
- Built and maintained strong relationships with investigators, study coordinators and cross-functional study teams.
- Contributed to high-quality clinical trial execution and inspection readiness across two countries.
Clinical Research Associate at SANOFI (2006-01 – 2009-12)
- Monitored clinical trial sites and ensured compliance with study protocols, ICH-GCP and applicable regulatory requirements.
- Managed relationships with investigators and site teams and supported patient recruitment, data quality and timely issue resolution.
- Conducted site initiation, monitoring and close-out activities.
- Contributed to inspection readiness and high-quality clinical trial execution.
Logistics Operator at DHL AVIATION (2004-01 – 2006-12)
- Worked within an international, time-critical aviation logistics environment.
- Developed a strong foundation in operational discipline, complex global supply processes and working effectively under strict timelines.
