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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. 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

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