BrightOwl Loader Loading

Experiences

Current Experience

  • EU Head Quality & Compliance Beerse, Belgium
    Since May 2005

    • Set the strategic direction and lead the department Quality & Compliance Management (QCM) Europe, which consists of general Quality & Compliance Management and Operational Management.
    • Optimize Good Laboratory Practices (GLP) quality systems, processes and documentation to ensure compliance, in line with increasing GLP
    • Collaborate with QA departments to ensure high quality standards, system- and study audits, evaluate observations, ensure efficient CAPA management and analyse trending
    • Active member in Enterprise and Pharma Sector councils to globalize, harmonize and simplify Quality and Compliance processes.
    • Prepare/accompany and evaluate regulatory site inspections (FDA, OECD,…)
    • Analyse, improve and harmonize business processes and procedures and increase transparency in order to reduce cycle times.
    • Participate in in/out-licencing projects from a data perspective.
    • Member of campus related councils (Technical Services, Environment/Health and Safety (EHS), Sustainability, Facilities governance, CPBW, EHS campus management council R&D, Enterprise Laboratory Instruments Strategy council, ...
    • Main departmental contact for Health Care Compliance / Business Integrity – collaboration with HCC officer.
    • Develop and maintain metrics for the global functional areas.
    • Ensure regulated and non-regulated compliant archiving procedures and e-archiving processes, developed according to part 11 guidelines.
    • Collaborate with US colleagues and lead global initiatives and projects.
    • Recruit, hires, retains, reviews and rewards staff based on performance as needed.
    • Chair the EU GLP steering committee
    • Network with external pharmaceutical compliance/QA colleagues
    • Set up a Belgian GLP forum and collaborate with Belgian Monitoring Health authorities.

Past Experience

  • EU Head Strateigic Alliances Beerse, Belgium
    January 1999 --- April 2005

    • Provide overall global strategic input and functional management support for the Global Strategic Outsourcing Department in conjunction with internal and external Business Partners/Customers.
    • Manage global supplier assessments & selections, GCP/GLP compliance, relationship management, and effective and efficient contract execution for Global Clinical (Drug) Development organization and other business units.
    • Develop and ensure standard outsourcing process methodologies, cost savings and metrics.
    • Establish and maintain strategic relationships with external senior management
    • Facilitate the issue escalation and resolution process for project teams.
    • Be a member of International and/or J&J Steering Committees, J&J Partnering Initiatives as required.
    • European Site management, manage local staff and act as the European contact for ex-US
    • Ensure sourcing compliance.
    • Recruit, hires, retains, reviews and rewards staff based on performance as needed.

  • Manager Project & Resource Planning & CRO Management
    January 1994 --- January 1999

    Key accomplishments: Set up a departmental planning system and support clinical teams from a workload/resource/budget planning perspective. Develop outsourcing processes, procedures, RFP and contract templates, guidelines, and provide training. Assess and select external service providers, support teams with contract management (CROs, Central Labs, ECG providers, Phase I units, IVRS, …). Build/maintain internal and external relationship management.

  • Scientific researcher Beerse, Belgium
    January 1987 --- January 1994

    Key accomplishments: Conduct in vitro and in vivo experimental research with Herpes Simplex, Influenza, and Rhino viruses.           

Personality

BrightOwl Assessment :
Innovative thinkingProblem solvingKindnessOptimismApproachabilityInterest in knowledgePerspective

Knowledge

BrightOwl Assessment :
Information TechnologymanagementBusiness AnalysisProject Portfolio ManagementVendor ManagementBusiness ProcessesSoftware DevelopmentPhysics

Skills and Expertise

BrightOwl Assessment :
Design IT solutionsCoach staffProvide supportAnalyze business needsImplement information systems
Self Assessment :
Quality Managementstartegic outsourcing strategic outsourcing

Education

  • Manager in Management courses from Vlerick school for management in 2002
  • MSc in Information Management from UA in 1996
  • Ing in Biochemistry from Faculty of West Brabant in 1990
  • BSc in Clinical Chemistry from Thomas Moore in 1985

Languages

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

Work Preferences

  • Notice Period:
    12 weeks
  • Locations I am interested in:
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • No