BrightOwl Loader Loading

Experiences

Current Experience

  • Consultant
    Since May 2014

    More than 19 years of experience in both global pharmaceutical company and CRO industry. Management of worldwide acting clinical QA function in different settings. Initiate and lead continuous process improvements. Detailed knowledge of GCP, GLP, GPvP and Clinical Regulations in US and EU and general Quality Management. Demonstrated ability to effectively interact with Competent Authorities. Excellent leadership and communication skills. Strong drive for results and problem solving skills with solid scientific background. Commitment to teamwork and flexibility. Auditing: independent review of systems/data according to internationally accepted standards for Investigational Product and Medical Device (e.g. study audits, system audits, protocol/report audits, CSV validation audits GAMP5) QA Support: Assistance, consultation and guidance on topicsinvolving quality, ethical and regulatory issues Compliance: Co-monitoring visits, TMF checks, inspection preparations Training: Coaching, teaching and instructing on GCP, GLP and GPvP, QMS and Auditing Inspection experience Directly involved in hosting inspections (more than 50) from FDA, EMA, MHRA, IGZ, DKMA, AFSSAPS, ANVISA, BfArM etc. on PV, GCP and GLP (sponsor, vendor and site inspections) Key areas of competence -Clinical: Clinical studies Phase I-IV, Bioequivalence, Pharmacovigilance, Data Management, Project Management, Monitoring, Archive/Document Management, Central Laboratories, Central Reading Services, e-Trails/IVRS. -Pre-Clinical: Toxicology, Pharmacology, Pathology, Central Laboratories -IT Validation: validation of computerised systems for clinical/pre-clinical, vendor audits -Risk-Based Approach in Audit and Compliance, including trend analysis and strategy setting -Setting up structures and processes for study/vendor oversight, escalation and Serious Breach internal review -Expert GCP, GLP and GPvP knowledge -Inspection Handling -Planning, conduct and reporting of Audits

Past Experience

  • Global Head Clinical QA
    September 2011 --- June 2014

  • Senior Director Corporate Audit Management - Pharmacovigilance Systems
    January 2011 --- September 2011

  • Director Corporate Audit Management - Pharmacovigilance Systems
    July 2010 --- February 2011

  • Director Quality Systems Europe
    January 2010 --- September 2010
    Line manager for 25 FTEs Responsible for Risk Management, Compliance Signals escalation, audit strategy, Training & Education programs, business improvement programs and maintenance for QMS for all Marketing Authorisation Holder's/Authorised Representative's responsibilities. Set-up and maintain Budgets and Timelines

  • Dir. BMRA Quality Systems & Compliance Europe
    January 2007 --- December 2009
    Responsible for Risk Management, Compliance Signals escalation, audit strategy and audit planning for Clinical Research in EU/EEA and Middle East for all Marketing Authorisation Holder's/Authorised Representative's responsibilities. Line-manager for 10 FTEs (QA Auditors and Quality System Consultants) including appraisal, competency mapping, training and education Set-up and maintain Budgets and Timelines Review and approve Quality Systems improvements projects Peer review of audit reports Trend Analysis and Focus setting for 3 compliance measurements (financial, GMP/GDP and GCP/HCC) Give training at CRA and Investigator's Meeting on Compliance, Auditing and Inspections

  • Associate Director Compliance
    January 2005 --- December 2006
    Line-management of 4 QA Auditors (incl. appraisal, review of audit reports, competency mapping, training and education). Set up and maintain Budgets and Timelines Liaison with international QA Departments Set-up system for departmental and individual goals, linked to mision and vision Trend Analysis and Focus setting Give training at CRA and Investigator's Meetings on Compliance and Auditing

  • Senior QA Auditor
    January 2004 --- December 2004

  • Clinical Process Manager
    January 2002 --- December 2003
    Quality Control/Quality Review Writing local SOPs and templates Certified Trainer Contact person for HQ for procedural documentation Hosting Inspection by Dutch IGZ

  • Clinical Project Leader
    January 2000 --- December 2001
    CPL for 2 oncology trials (phase II and III) Organising Investigator's Meetings Co-Monitoring new CRAs Set-up and maintain Budgets and Timelines Line-manager for 3 CRAs Responsible for trial deadlines/Database locks Monitoring Investigator's Sites

  • Lead CRA
    January 1998 --- January 2000
    Lead CRA for 5 pulmonary trials (phase I, II and III)

  • Clinical Trial Manager
    January 1997 --- December 1997

  • Clinical Research Associate (CRA)
    January 1996 --- December 1996

  • Intaker and Financial Service Provider
    January 1994 --- December 1995

  • Voluntary Worker Department of Gatro-Entereology, Internal Medicine
    January 1994 --- January 1994

  • Alternative Military Service
    January 1992 --- January 1994

Knowledge

LinkedIn Assessment :
Medical DevicesGCPClinical trialsPharmaceutical IndustryClinical DevelopmentCTMSSOPRegulatory affairsCRORegulatory submissionsBiotechnologyICH-GCPClinical researchPharmacovigilanceChange ControlFDAQuality SystemsQuality AuditingoncologyGXPQuality Assurance (QA)Good Laboratory Practice (GLP)Regulatory Requirements21 CFR Part 11SOPValidation

Education

  • Master of Science in Medical Biology from Catholic University Nijmegen, The Netherlands in 1993
  • VWO in Beta from Anton van Duinkerken College Veldhoven, The Netherlands in 1987
  • HAVO in Beta from Anton van Duinkerken College Veldhoven, The Netherlands in 1985
  • MAVO in from Selsterhof Veldhoven, The Netherlands in 1983

Languages

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

Work Preferences

  • Work From Home:
    Yes, 5 to 0 days per week
  • Work Regime:
    BrightOwl freelancer :    20-40 Hours per week
  • International:
    Yes

Area / Region

Munich, Germany

Others

Driving License
  • Yes