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Summary

Regional (European) Quality Manager in pharmaceutical industry; dotted line oversight to in country Quality Managers. Focus on regulatory compliance, operational efficiency & strategical alignment Specialties: Compliance management in the areas of GCP/clinical research, pharmacovigilance & medical promotion. Experience with process development, implementation, knowledge management, risk management, information & records management, internal auditing, lean/ six sigma, change management, project management

Experiences

Current Experience

  • Head Medical Quality and Compliance (EU, Canada, Australia/NZ, Korea)
    Since November 2010
    Quality and Compliance and Inspection Readiness for regional and country Medical operations. Dotted line oversight for Country Quality and Compliance Managers: Quality Strategy; Quality Planning; Promotional Compliance; Inspection Readiness; SOP Development & Implementation; Training Compliance & Documentation; Continuous Improvement.

Past Experience

  • European Quality and Compliance Officer
    September 2009 --- October 2010
    Quality & Compliance Management for European Pfizer Country Organizations. Dotted line oversight for Country Quality and Compliance Managers: Quality Strategy; Quality Planning; Promotional Compliance; Inspection Readiness; SOP Development & Implementation; Training Compliance & Documentation; Continuous Improvement.

  • Quality Standards Manager
    July 2003 --- January 2010
    Responsible for quality strategy, quality planning, management of internal quality system: focus on improving quality & regulatory compliance, operational efficiency and strategical alignment. .

  • Clinical Research Associate (CRA)
    May 2000 --- August 2003
    Responsible for study management and monitoring for several clinical studies.

  • Certified Clinical Perfusionist
    August 1988 --- May 2000

  • Physiotherapist
    July 1986 --- July 1988

Knowledge

LinkedIn Assessment :
Pharmaceutical IndustryChange ManagementQuality ManagementPharmacovigilanceQuality SystemProject ManagementClinical researchmanagementGCPRegulatory affairsClinical trialsSOPSOPoncologyStandard Operating Procedure (SOP)BiotechnologyGood Clinical Practice (GCP)Clinical Development

Education

  • in from Erasmus Medisch Centrum-Department Cardio-Thoracic Surgery in 1992
  • Bachelor in fysiotherapie from in 1986

Area / Region

Netherlands

Others

Driving License
  • No