Senior management professional with 25+ years of combined pharma, CRO, academic and laboratory experience in the pharmaceutical research industry. Intrinsically motivated to make a difference in any position. Keenly interested in all aspects of (medical) research and healthcare, and excited to learn and contribute to success stories.
A scientist by education and a generalist by nature, I have a broad experience in a variety of roles of increasing responsibility, across several functional areas and with significant international exposure. Functional experience includes project management, quality assurance, regulatory compliance, vendor management, sample management, logistics, investigator services, in addition to business development and general management with HR and P&L responsibility.
I enjoy developing individuals (including self) and teams, improving general business performance and managing change. Looking for a position in a stimulating environment that allows applying general management skills (primarily) and subject matter expertise (where relevant). Not currently open to relocation, but willing to travel and proven to be successful in multi-cultural, matrix management structures.
Since September 2017
Responsible for overseeing operational activities across all laboratory departments as well as departments that support project set-up, project execution and the delivery of results. Fostering collaboration across EU and US locations and functions. Implementing and supporting cross-functional teams to address operational challenges, identify opportunities and implement enhancements.
Recent speciality focus includes data protection (appointed as Data Protection Officer in relation to the EU-GDPR), in vitro diagnostic medical device developent (PMA and CE-IVD pathways), clinical trial logistics and addressing regulatory compliance questions.
VP, Managing Director, CLS Global Operations Mechelen, BelgiumJuly 2015 --- August 2017
Senior Global Director, Logistics Operations Mechelen, BelgiumJanuary 2013 --- July 2015
Managing Director Mechelen, BelgiumJuly 2007 --- July 2015
Global Director of QA Mechelen, BelgiumSeptember 2005 --- July 2007
Director of QA, Europe Mechelen, BelgiumNovember 2000 --- August 2005
(Senior) Quality Assurance Manager Brussels, BelgiumMarch 1998 --- October 2000
(Senior) QA Auditor Brussels, BelgiumApril 1995 --- March 1998
CRA, Local Project Coordinator Brussels, BelgiumJuly 1993 --- March 1995
AdaptabilityAnalytical thinkingApproachabilityAuthenticityCollaborationCoordinationCritical thinkingDependabilityDiligenceFlexibilityInterest in knowledgeOptimismOrganizationPerspectiveProblem solvingResiliencyResponsibilityResult OrientedStrategic thinkingTrust
NegotiationAnalytical proceduresAuditingBiologyBiomarkersBudget ManagementBudget ProcessBusiness StrategyCancer ResearchChange ManagementClinical researchClinical SuppliesClinical trial audits and inspectionsClinical trial managementCoachingCommunication SkillsCompliance with regulationsContinuous ImprovementContract negotiationCROCross-functional team leadershipDiagnosticsDrug development processDrug regulatory authoritiesDue DiligenceEnglishGXPHealthcare industryImmunohistochemistry (IHC)In vitro diagnostics (IVD)Informed Consent ProcessInternational RelationsISO 13485ISO 17025ISO 9001Knowledge of the drug development processLaboratory ResearchLeadershipLife SciencesLogisticsmanagementMedical DevicesMergers & AcquisitionsMicrosoft OfficeMolecular DiagnosticsOncology Clinical ResearchOperations ManagementOutlookPathology labspeople managementPharmaceutical DevelopmentPhases of clinical development (phase I to IV)PresentationsPricingProblem SolvingProcess improvementPublic SpeakingQuality Assurance (QA)Quality Management System (QMS)Regulatory ComplianceRestructuringRisk ManagementRoot Cause Analysis (RCA)Standard Operating Procedure (SOP)StrategyTeachingTeam ManagementTranslational Research
Skills and Expertise
Create SOPsAnalyse growth / improvement potentialAssign activitiesAttend steering committeeAdvise on strategyCoach staffCommunicationContract approvalCoordinationCreates a collaborative team environmentDevelop ICH/GCP compliant processesDirect co-workersEstablish contractsEstablish professional relationships with partnersExecute internal/external quality assurance assessmentsFollow-up of Quality Management System (QMS) processesImplement Key Performance Indicators (KPI's)Implement Quality Management System (QMS)Lead teamsMaintain Quality Management System (QMS)Manage complexityManage vendor budgetsMonitor Key Performance Indicators (KPI's)NegotiationOrganise meetingsPeople managementPrepare responses to health authority queriesProvide trainingReview vendor metricsSelect contractors Train StaffWork cross-functionally
PhD in Developmental Biology from KU Leuven, Belgium in 1997
Post Graduate in Life Sciences Teacher from KU Leuven, Belgium in 1991
Master in Biology from KU Leuven, Belgium in 1989