Guillaume BOIGEY


En résumé

Mes compétences :
principal investigator
Deviation, OOS, OOT, CAPA, Change request Manageme
development of quality culture and Regulatory Comp
quality management (FDA, ANSM, other agencies)
cell culture
references and critical reagents management
project management
laboratories technical support
Customer technical support


  • Sanofi Pasteur - Quality Control Manager

    Lyon 2010 - maintenant Quality Control Manager Virology (Sanofi-Pasteur, Marcy)
    * Management of 5 technical assistants on three vaccine analytical laboratories control (including two team manager and 25 technicians).
    * responsible for the development of quality culture and Regulatory Compliance in laboratories in line with the quality policy Site and pharmaceutical quality standard (cGMP, GMP). ;
    * Pilot quality events and commitments and guarantees their timely manner treatment (deviation, CAPA, OOS and Change Management (CCR)): Principal Investigator ;
    * In charge of a team of investigators (companionship and certification). ;
    * Representing the laboratories outside site and during inspection (ANSM, FDA...) ;
    * Ensure the reliability of results, approval of results in LIMS ;
    * TrackWise deviation and Change control ;
    * Approval and writing of technical documents for the laboratories (SOPs, protocol, report) ;
    * Ensure the maintenance of the validated status of analytical methods ;
    * In charge of the scientific and technical support in the laboratories, resolving technical and analytical issues in laboratories. ;
    * Coordinating technical projects, pilot their planning (internal projects and / or external) ;
  • Synbiotics - Technical Director

    2006 - 2010 Technical Director-Synbiotics (CA 20 M EUR , Lyon)-Synbiotics designs, develops, produces and markets veterinary Diagnostics tools (ELISA, lateral flow)
    * In charge of services R & D, industrialization, quality control and production (manufacturing, biochemistry, culture)
    * management of 2 team manager and 20 technicians; supervision of activities, technical expertise ;
    * Member of AFNOR working groups ;
    * Management of R&d projects and quality control activities (product release) ;
    * Ensure compliance with deadlines, costs and regulatory requirements ;
    * Participation in the continuous improvement of quality management system (Pilot) ;
  • Diffchamb - R&D project Manager

    2002 - 2005 Sept 2002 - Dec 2005 : R&D project Manager Biotechnologies- Diffchamb (CA 5 M EUR , Lyon)-Diffchamb designs, develops, produces and sells Diagnostics tools for agri-foods
    * R&D project management: bibliographic study, development and validation of methods (ELISA, microbiology), analyze and results presentation ;
    * Writing of technical documents for quality control and production ;
    * Transfer of new product from R&D to production ;
    * Installation and adjustment of ELISA workstation ;
    * training and technical expertise for customers of the agri-food sector ;
    * Customer technical support (Europe) ;



    Dijon 2002 - 2002 Masters Degree

    MASTER degree in microbiologie ENSBANA Dijon – mention AB
  • Université Nantes (Nantes)

    Nantes 2001 - 2001 Major in Immunologie, Université de Nantes –with honours


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