Senior consultant - Analytical Technical Integrator
Since June 2015
As Analytical Technical Integrator in the Analytical Development department, I am responsible for developing analytical project strategy, managing planning and execution of analytical deliverables and coordinating project transfer between phases (early, late development and commercial launch) of vaccine projects, including supporting regulatory filings.
Senior consultant - PDMS Lifecycle Management & Specifications
January 2015 --- June 2015
Project lead for the implementation of the ICH Q3D guideline for elemental impurities. Project manager for leading and coordination project teams within the analytical organization.
Interim Manager - Technical owner PDMS Lifecycle Management & Specifications
July 2011 --- December 2014
Responsible for the maintenance/oversight of all legacy specifications (drug substance and drug product) and methods (coordination and first line support) for small molecules. Central point of contact for analytical project information. Project manager for leading and coordination project teams (internal and external experts) within the analytical organization. Project lead for the implementation of the EMA guideline for metal impurities.
Senior Consultant - Business Excellence Engineer
April 2011 --- June 2011
Item optimalization project concerning raw materials and supporting pharmaceuticals.
Senior Consultant - QA Compliance F&E
October 2010 --- February 2011
Review and approval of validation (equipment), calibration and maintenance documents, follow-up on deviations, CAPA´s, change control, review and approval of procedures, protocols and reports. Follow-up on correct implementation of the guidelines.
Senior Consultant - Analytical Inspection Readiness Program Coordinator
February 2010 --- September 2010
Lead of a project team that prepares the analytical part of a new product. Coordination of the pre-approval inspection readiness program for the QC-lab.
Senior Consultant - QA Compliance for QC
June 2009 --- January 2010
Teamlead QA/QC. Coordination of the activities required to meet the quality standards for the QC environment: follow-up on deviations, CAPA´s, leading the QC-investigations, change control, internal audits, review and approval of procedures, protocols, reports, stability documentation. Follow-up on correct implementation of the guidelines.
Manager Change Control
April 2008 --- May 2009
Expert in change control for chemical process changes. Define impact assessments and actions on different areas (regulatory, analytics, validation status, EH&S, logistics, stability, documentation). Central contact person for Chemical Production Belgium for process change control for the Wordwide Chemical Production Sites within J&J.
Project Manager New Process Introductions
January 2002 --- March 2008
Project Manager for leading multidisciplinary project teams in an active pharmaceutical ingredient (API) production facility. This function included technology transfer activities, introduction of new chemical processes, process validation and scale-up according to cGMP, EH&S, quality and compliance guidelines and fulfil the standards for process-robustness and cost-conscious. Collaborate on preparation of the chemical part of the regulatory dossier and preparation of pre-approval inspections.
Validation and System Engineer
January 2001 --- December 2001
Validation of commercial chemical processes Equipment qualification Cleaning validation
Project Leader Specification Management Chemicals
May 1997 --- December 2000
Management of the analytical product specifications for the purchased chemical products, the intermediates, the active pharmaceutical ingredients (API) and the plant and material protection products for the worldwide chemical production of J&J.
Quality Assurance Associate
April 1992 --- May 1997
Implementation of a quality system according to the GMP standards for the chemical production sites in Belgium (Geel/Beerse). Batch record review, deviation handling, product release, review and writing of procedures, audits, training. QA-person in all kind of projects.
Quality and Sterility Expert
July 1990 --- March 1992
Implementation of a quality system according to the GMP standards for assembling, packaging, sterilisation and distribution of medical devices.
Analytical thinkingApproachabilityAssertivenessAttention to detailCollaborationCommunicativeCoordinationCritical thinkingFlexibilityProactivityProblem solvingResponsibilityResult OrientedSelf-disciplineService orientedTrustStrategic thinking
Biochemistry Phase I R&D21 CFR Part 11Analytical ChemistryAnalytical Method ValidationAnalytical methodsAnalytical proceduresAnalytical techniquesApplicationsAssay developmentBudget ProcessCAPAcGMPChange ControlChange ManagementCharacterizationChemistryChemistry, Manufacturing, and Controls (CMC)ChromatographyCMCCommunication SkillsCompetitive AnalysisComplianceCompliance with regulationsContinuous ImprovementCross-functional team leadershipCurrent Good Manufacturing Practice (CGMP)Drug substancesEarly development stageEnglishFailure Mode and Effect Analysis (FMEA)FDAgas chromatographyGMPGood Manufacturing Practice (GMP)ICH guidelinesIMPDINDKnowledge of the drug development processLife SciencesManagement ConsultingMarketing Authorisation Application (MAA)Microsoft ExcelMicrosoft OfficeMicrosoft PowerpointMicrosoft ProjectMicrosoft WordMitigationMS ProjectNew Drug Application (NDA)Organic ChemistryOutlookOutsourcingPharmaceutical IndustryPharmaceutical DevelopmentPhases of clinical development (phase I to IV)Position PaperPowerPointProblem SolvingProject CoordinationProject ManagementProject PlanningProtocolQA complianceQC releaseQualificationQuality Assurance (QA)Quality AuditingQuality Control (QC)Quality ManagementQuality Management System (QMS)Quality SystemsRegistration of the productRegulatory affairsRegulatory ComplianceRegulatory RequirementsRegulatory StrategiesRegulatory submissionsReport WritingRisk AssessmentRisk ManagementRoot Cause Analysis (RCA)SAPSmall moleculesStability testsStandard Operating Procedure (SOP)SterilizationStrategyStudy protocolsTeam BuildingTeam LeadershipTeam ManagementTeamworkTechnology transferUnderstanding of regulatory guidelinesValidationVaccines
Skills and Expertise
Analytical skills Build the CMC development plan Create SOPsAdvise on strategyAssess product quality issuesAssess quality process issuesAssign activitiesassess the needs of the project(s)/program(s) and make changes in process, work flow and/or assignments.Assist with proceduresAttend at steering committee meetingsAttend seminars, courses and meetings within and outside the companybudgeting of R&D activitiesChemistry Manufacturing and Controls (CMC) activitiesCollaborate with project teamCommunicate effectively on different company levelsCommunicationCoordinate CMC-activitiesCoordinate projectsCreate SOPsCreates a collaborative team environmentDevelop Quality Risk Management (QRM) initiativesEstablish professional relationships with partnersEvaluate stability data and impurity identification/synthesisExecute internal/external quality assurance assessmentsFollow-up of external auditsFollow-up of internal auditsFollow up training programsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesGastrointestinal diseasesImplement Quality Management System (QMS)Interpret analytical resultsLate-stage regulatory filing (MAA, BLA)Lead teamsMaintain Quality Management System (QMS)Maintain strong relationshipsManage complexityManage global quality standardsManage laboratory proceduresManage multiple projectsManage projects resourcesManage Quality Management System (QMS) documentationManage risksmanaging a small teamMonitor Key Performance Indicators (KPI's)Organise meetingsOral presentationOrganise steering committeePrepare CMC source documents Prepare responses to health authority queriesPresent at steering committeeproject managementRegulatory documentationRegulatory submissionsRelease productsRepresent CMC team Review protocolsReview manufacturing documentationReview quality control activitiesReview quality policiesReview reportsReview study protocolsReview the interpretation of dataSolve problemsWork cross-functionallyWrite documentsWriting regulatory documentsWritten presentation
Master in Biochemistry from Katholieke Hogeschool Limburg in 1988
Master in the chemistry - biochemistry in from Katholieke Hogeschool Limburg in 1988
Training and Certification
FPX Project Leader in 2015 Training
Visual Workflow and Risk Management in 2015 Training
Project Management in 2004 Training