Global Quality Lead
March 2011 --- January 2016
Bringing business process owners and subject matter experts together to agree on the problem statement of a quality issue, identify true root causes and develop a risk-based CAPA plan. Design and deliver interactive case-based training on the CAPA process R&D representative in company-wide Lean Sigma CAPA process improvement project.
Associate Director, Global Quality Management
March 2003 --- February 2011
Leading a team of Quality Managers (QM), focused on a risk-based approach to ensure efficient and effective quality systems and GCP compliant best practice are employed by the clinical organization.. Expanding the QM footprint from European to truly global by maximizing the matrix organization. Expanding the QM responsibilities to include Medical Affairs support in regions were needed. Conducting co-monitoring visits to identify and treat business risks. Establish and maintain repository of country-specific clinical trial requirements. Due diligence for local vendor selection. Trainer for the corporate 'Standards of Business Conduct and Ethics' program.
Global Quality Manager, Central & Eastern Europe, Russia, Israel and Turkey
September 2001 --- February 2003
Expert counseling and training in GCP and company procedures to clinical staff. Supporting local implementation of global processes and procedures, developing aligned local procedures, reflecting local/regional regulatory requirements. Maintaining inspection-readiness, responding to audits and initiating process improvement. Quality oversight of outsourced studies. Regulatory vigilance.
GCP Compliance Auditor
October 1995 --- August 2001
BS EN ISO 9001 LEad Auditor, conducting audits of clinical study sties in Europe, South Africa, and the middle East in various therapeutic areas. Conducting internal system audits Managing of the company's Procedural Document System. Designing, delivering and managing training of clinical staff in GCP and Procedural Documents.
European Clinical Program Coordinator
April 1994 --- September 1995
Designing and delivering training of clinical staff in GCP, monitoring skills and Procedural Documents. European representative in the company's clinical research training coordination committee, standardizing and implementing a global monitor's training program. Publishing Quality and project-related newsletters. Supporting development and implementation of processes and procedures.
Informatics Consultant, Trainee
April 1988 --- August 1988
Analytical thinkingCritical thinkingFlexibilityInterest in knowledgeProblem solvingResult OrientedService orientedIndependence
AuditingBusiness Process ImprovementBusiness ProcessesCAPAClinical monitoringClinical operationsClinical researchClinical trial audits and inspectionsClinical trialsComplianceCompliance with regulationsContinuous ImprovementCross-functional team leadershipGood Clinical Practice (GCP)ICH guidelinesInformed Consent ProcessKnowledge of the drug development processMicrosoft OfficePhases of clinical development (phase I to IV)Problem SolvingProcess improvementQA complianceQuality Assurance (QA)Quality AuditingQuality Management System (QMS)Regulatory RequirementsRisk ManagementRoot Cause Analysis (RCA)
Skills and Expertise
Write documentsWork cross-functionallyWork collaboratively with the other members of the clinical research team Verify dataUnderstand protocolsTrain StaffSupport due diligence assessmentsSolve problemsReport serious adverse events (SAE)Quality control processProvide trainingProvide input to process improvement initiativesPrepare internal auditsPrepare external auditsPlan work to meet objectives and deadlinesOrganise meetingsOral presentationObserve trends in dataManage Quality Management System (QMS) documentationMaintain Quality Management System (QMS) Analytical skills Analyze data Create SOPs Monitor a clinical study Use content management systemsAdjust processes and methodsAdverse event reportingApprove suitability of patient information and consent documentsAssess quality process issuesAssist with site trainingAttend investigator meetingAttend seminarsAttend seminars, courses and meetings within and outside the companyCoach and provide guidance to clinical staff.Coach clinical staffComplete case report form (CRF)Create SOPsCreate standard operating procedure (SOP)Develop Quality Risk Management (QRM) initiativesDevelop training materialsEthics committee submissionsFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesIdentify risksImplement Quality Management System (QMS)Liaise with professionals in other divisions of the company as requiredManage risksTrain off site staffTrain on site staff
Master's degree in physiotherapy from University of Leuven in 1985