As Lead Auditor, auditing suppliers active in the Medical Device industry for compliance to ISO 13485, Medical Device Directive and Medical Device Regulation.
Class IIb & Class III Devices: Cardiac Catheter.
Implementation of a QRM compliant to MDR 2017/745 for a Start-Up manufacturing Cardiac Catheters.
QA Consultant Medical DevicesMechelen, Belgium
Since February 2018
Auditing companies active in the Medical Devices manufacturing sector for compliance with ISO 13485, Medical Device Directive and Medical Device Regulation.
Gap Analysis and Action Plan for transition from Medical Device Directive to Medical Device Regulation.
Technical & Scientific Affairs SpecialistJanuary 2015 --- October 2017
Lab Study Manager for GSK BiologicalsMay 2011 --- December 2014
External Labs & Project Coordinator for GSK BiologicalsOctober 2009 --- May 2011
Head of Biological Testing LabNovember 2001 --- March 2004
Junior Technical Project ManagerJune 1996 --- January 2001
Research associateJanuary 1990 --- October 1995
AdaptabilityAnalytical thinkingAssertivenessApproachabilityCollaborationCommunicativeCoordinationCreative thinkingCritical thinkingCuriosityEfficiencyFlexibilityInnovative thinkingInterest in knowledgeKindnessOptimismOrganizationPerspectiveProactivityProblem solvingResiliencyResponsibilityResult OrientedSelf-confidenceSelf-disciplineTrustAuthenticityDiligenceSociabilityWillingness to compromise
Skills and Expertise
Analytical skills Assure medical quality Build and manage the Trial Master File (TMF) Create SOPs Develop clinical trial protocols Interact with nurses Interact with physicians Interpret data Molecular Diagnostics Monitor a clinical study Search literature on clinical trials Technology research Use content management systems Write protocolsAct as the main line of communication between the sponsor and the investigatorAdjust methodsAdjust processes Administer logisticsAdminister supply requestAdminister, maintain and co-ordinate the logistical aspects of clinical trialsAdverse event reportingAdvise on strategyAnalyze data/information to determine potential relationships.Analyze proteinAseptic techniquesAssess business and scientific ethicsAssess product quality issuesAssess quality process issuesAssess site feasibilityAssess subject safetyassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assign activitiesAssist study siteAssist with experimentsAssist with proceduresAssist with routine testsAssist with site trainingAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyAttend steering committeeBiomarker Researchbudgeting of R&D activitiesCell cultureCoach and provide guidance to clinical staff.collaborate in research projects at universitiesCollaborate with medical teamCollaborate with PI and institution to respond to any audit findings and implement-approved recommendations.Collaborate with principal investigatorCollaborate with project teamCommunicate effectively on different company levelsCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct literature searchesConduct maintenance visitsConduct research at universitiesConduct site initiationConduct supply issue resolution activitiesConfirm protocol compliancecoordinating research projectsCoordinationCreate SOPsCreates a collaborative team environmentData entryDesign clinical presentationDesign scientific experimentsDesign scientific projects (in biology)Develop strong internal relationships with stakeholdersDirect co-workers to achieve resultEstablish professional relationships with partnersEvaluate physico-chemical dataEvaluate physico-chemical data of lab scale/pilot scale batchesExecute scientific projectsFacilitate sponsor monitoring visitsFollow up projectsFollow-up of external auditsFollow-up of internal auditsHandle incidentsIdentify and provide training to trial team and associated staffInteract with nursesInteract with physiciansInteract with pre-clinical scientistsInterpret analytical resultsInterpret dataInterpret research resultsInterpret scientific dataLead teamsLiaise with doctorsLiaise with professionals in other divisions of the company as requiredLiaise with research teamLiaise with research team in order to accurately collect and record dataManage Clinical Trial Management System (CTMS) Manage clinical suppliesManage contractors Manage laboratory proceduresManage multiple projectsManage research projectsManage risksmanaging a small teamObserve trends in dataOptimize assay performanceOperate research equipmentOral presentationOrganise meetingsOrganize scientific projects (in biology)pcrPeople managementPerform routine testsPlan experimentsPlan work to meet objectives and deadlinesPrepare external auditsPrepare internal auditsPrepare investigator brochuresPresent at steering committeePresent data at congressProcure and prepare samplesproject managementProvide support for scientific and/or technical projectsProvide technical supportProvide trainingPublication of articlesQuality control processR&DRead medical literatureReport technical problemsReview data interpretationReview protocolsReview quality control activitiesReview the interpretation of dataSearch literature on clinical trialsSelect contractors Set up research projectsSetup of research equipmentShipment of biological specimenSupervise analysts and researchersSupervise techniciansSupervise trial suppliesTeach university studentsTrain off site staffTrain on site staffTranslate protocol into packaging and labeling requirementsTranslate strategy into operational plansUse laboratory techniquesUse western blotting techniqueVerify dataWork collaboratively with the other members of the clinical research team Work cross-functionallyWork with coordination and data management teamsWrite documentsWritten presentation
Master in Molecular Biology & Biotechnologies. in Biotech/Molecular Biology from Université libre de Bruxelles in 1989
Biochemical Engineer in Biotechnologies/Biochemistry from Institut Meurice - Haute Ecole Lucia De Brouckère. in 1987
Training and Certification
CRA Training in 2009 Training
PRINCE2 in 2018 Certification
Six Sigma Yellow Belt in 2018 Certification
Fire Marshal in 0000 Certification
Red Cross Medic in 0000 Certification
Six Sigma Yellow Belt in 0000 Certification