Aurore Nègre

Global Quality System Manager within SANOFI at IMPAC Ingénierie (MPA Group)
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Contact Information
us****@****om
(386) 825-5501
Location
Greater Montpellier Metropolitan Area, FR
Languages
  • Français Native or bilingual proficiency
  • Anglais Full professional proficiency
  • Espagnol Limited working proficiency
  • Langue des Signes Françaises Elementary proficiency
Skills

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Bio

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Credentials

  • OSSAD PYX4 Management Process Modeling
    AFME
    Dec, 2015
    - Nov, 2024

Experience

  • IMPAC Ingénierie (MPA Group)
    • France
    • Engineering Services
    • 1 - 100 Employee
    • Global Quality System Manager within SANOFI
      • Jan 2017 - Present

      In Cold Chain management:=> R&D Global Quality Head in IMP Cold Chain Management -Centralize and assess in close collaboration with quality & analytical teams, temperature excursions from incoming worldwide R&D clinical products and communicate any quality impact to Sanofi affiliates-Harmonize the temperature excussion management process on all R&D Sites-Collect, analyze and share with R&D Global Quality Board, R&D Quality Sites Board, R&D Clinical Supply and distribution management teams all KPIs related to temperatures excursions of investigational products sent from R&D Sanofi sites -Assume role of Global Quality Representative for the TEX application (Temperature EXcursions) – tool implemented in Sanofi and Sanofi Pasteur sites – Involved in the user requirements definition, user acceptance tests, quality documents review and responsible of all users e-learning conception and training of R&D quality teamsIn Complaint Management:=> Global Complaint Coordinator Back-up-Centralize and follow up of R&D complaints from worldwide clinical trials Show less

    • Lean Leader for Sanofi R&D
      • Jan 2018 - Feb 2022

      Inspection and Audit Process Optimization for a Sanofi R&D site (France): -communication flow-logistic preparation-roles and responsabilities definition-documentation review => WorkShop Leader: -preparation-lead-follow-up=> Lean tools: Voice of Employees, VSM, MUDA, VSD, Prioritization Matrice

  • Sanofi
    • France
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Global Complaint Coordinator
      • Jul 2016 - Dec 2016

      Fixed term contractUnder the direct supervision of VP R&D Quality Head and R&D Quality Risk Manager-Participate to the transfer activity from US to France ensuring business continuity in challenging timelines (less than 2 months)-Centralize and follow up of R&D complaints from worldwide clinical trials-Collect and analyze regular reporting related to complaint management

    • Global Risk Management - Internship
      • Jan 2016 - Jun 2016

      Participate under the R&D Quality Risk Manager Head’s responsibility to:-The implementation of a Human Error Prevention Program within Sanofi R&D sites -The deployment of a new quality risk assessment tool (Site Risk Mapping) within Sanofi R&D sites-The improvement of quality documents - Topics covered: Management of deviations, Escalation of quality events, Assessment of quality events

  • International Montessori School La Maison Des Enfants
    • Castelnau Le Lez (34)
    • Montessori Education Teacher
      • Jun 2013 - Jul 2015

      Create a new 3-6 years old Montessori classroom Create a new 3-6 years old Montessori classroom

  • La Folie En Tête - Artistic and cultural events association for kids
    • Alpes Maritimes (06)
    • Cultural Events Planner
      • Oct 2009 - Jul 2011

      Artistic and cultural events association for kids - Business development - Financial search: public subvention, call for project, private donation - Communication strategy - Partnership: public and private, financial, educational, events and social Artistic and cultural events association for kids - Business development - Financial search: public subvention, call for project, private donation - Communication strategy - Partnership: public and private, financial, educational, events and social

  • Club de Voile Municipal
    • Palavas Les Flots (34) & La Grande-Motte (34)
    • Sailing Instructor
      • Jul 2003 - Aug 2005

      Leadership - Safety - Education Catamaran, dinghy & optimist Leadership - Safety - Education Catamaran, dinghy & optimist

Education

  • Université de Montpellier
    Master 2, Project Management
    2015 - 2016
  • IRTS-LR Montpellier
    Special Education Teacher - Educateur de jeunes enfants, Formation et enseignement à la petite enfance
    2011 - 2014
  • SKEMA Business School
    Master 1 Management – Business School
    2007 - 2009
  • Lycée international Jules Guesdes
    HEC - Preparatory class, CPGE
    2005 - 2007
  • Centre Nautique Pierre Ligneuil
    Sailing Instructor, Catamaran, dinghy & optimist
    2005 -
  • Sanofi
    Lean Leader
    2018 - 2018

Community

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