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Experiences

Current Experience

  • QRM Lead for R&D Laboratories (Quality and Risk Management) - GxP environment
    Since October 2014
    Promote the development of a quality culture, support implementation and embedding of quality frameworks and standards consistently across the respective R&D vaccines laboratories. • Ensure local training created to meet departmental needs is aligned with R&D training strategy. • Promote simplification of process and documents in collaboration with the Business owners • As risk facilitator supports the Vaccines risk management framework implementation, including risk identification, assessment and prioritisation, definition of mitigation plans and monitoring • Coordinate and interpret transversal risks and provide recommendations • Coach business on self-assessment principles, develop transversal tools and implementation plans. Perform long term trending and reviews with relevant management and leadership teams. • Support audit and inspection awareness, coordinate their preparation and supporting activities and ensure CAPA implementation and effectiveness. Provide oversight and integrate audit outcomes and learnings. • Resolve consultancy questions using a risk based approach, as appropriate will liaise and/or escalate further to relevant partners. • Ensure consistency in assessment, resolution and escalation of critical transversal issues. • Identify the appropriate Subject Matter Experts for consultation of new/draft legislation and support the impact assessment on existing operations and follows up on implementation. • Support the roll-out of Compliance/Values initiatives, by tailoring initiatives to laboratories • Ensure learning from CAPA and Regulatory intelligence is integrated in process and associated controlled documents and training at all area levels • Workstream leader for improving risk management & management monitoring in the context of Third Party Oversight • Promote knowledge and information sharing

Past Experience

  • Head of Quality Operations & EHS team for Internal Clinical Laboratories and external partners
    April 2010 --- September 2014
    Manage, develop, improve and harmonize the quality system of GSK Vaccines clinical laboratories and monitor the quality level of subcontracted laboratories (central and research labs). Coach people and facilitate consistent EHS, quality and risk attitude. Lead and direct quality & EHS staff by providing directions, expectations, support, coaching and advice as well as by performing regularly reviews of performances and creating opportunities for development

  • Quality Assurance Expert in GxP for Internal Clinical Labs
    February 2007 --- April 2010
    Control the compliance of Belgian R&D labs for clinical testing Check the quality of data generated by clinical teams Support external quality audits and inspections. Manage interaction with auditors Support labs to meet good quality level and control their quality level Deviations follow-up Internal audits

  • Quality officer and GLP inspector
    November 2004 --- January 2007
    Development of a quality system for the collection of micro-organisms based on the ISO 17025 Training of personnel. Performing internal audits (ISO 17025, ISO 9001) and GLP inspections in external companies

  • Quality Advisor
    November 2002 --- November 2004
    Training of personnel of the University in quality matters, guidance of different units, laboratories or spin-off associated companies in the implementation of a Quality System (ISO 17025, ISO 9001 or GLP) and performance of internal audits

Personality

Self Assessment :
Self-confidenceAdaptabilityAssertivenessCollaborationEfficiencyFlexibilityStrategic thinkingSelf-disciplineResult OrientedResiliencyProblem solvingProactivityOptimismInterest in knowledgeCoordinationCommunicative

Knowledge

Self Assessment :
Risk Management R&DBusiness Process ImprovementCAPAChange ControlClinical trial audits and inspectionsWriting Study Procedures and SOPsTrainingTeam LeadershipSAPRisk AssessmentQuality SystemsQuality ManagementQuality Assurance (QA)QA complianceProject ManagementProblem-solving methods and troubleshootingPrinciples and ethics of clinical researchPre-clinical researchpeople managementLaboratoryImmunologyICH-GCPGXPGood Manufacturing Practice (GMP)Good Distribution Practice (GDP)Good Laboratory Practice (GLP)Continuous Improvement
LinkedIn Assessment :
GLPGCPISO 17025FDAQuality AssuranceClinical trialsClinical researchGXPQuality SystemAnalytical ChemistryCAPAValidationChange ControlBiotechnologyPharmaceutical IndustryLaboratorySOPSOP

Education

  • in Bio-engineer in Chemistry and Bio-industries from Faculté universitaire des Sciences agronomiques de Gembloux in 2002
  • Master in physiology and cellular biology in from Université de Liège in 2000
  • Bachelor Degree in biochemistry in from Université Paris Sud (Paris XI) in 1999

Languages

BrightOwl Assessment:
Self Assessment:
English
Full Proficiency
French
Native
Dutch
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    QA Lead Quality Assurance (QA) Manager Quality manager, Product Manager, Senior QA, QA Assurance
  • Work From Home:
    Yes, 0 to 2 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes