Antoine BOULIER

En résumé

Entreprises

• Galderma - Corporate Operational QA Manager

  Courbevoie 2016 - maintenant - Member of the global QA organization
  - Responsible to monitor and promote Operational Quality (release, QC, deviations, CAPA…) within the Galderma production sites
  - Supervise & coordinate the sites CMO Quality Teams in the scope of Cosmetics, Drugs, Food Supplements and Medical Devices.
  - Enhance quality continuous improvements actions
  - Develop quality business excellence approach across sites & CMOs.
  

• Abbott Laboratories - Product Support & Compliance QA Manager

  Rungis 2013 - 2016 - Member of the global QA organization
  - Management of the Change Request Process
  - Write / Review and Approve CMC documents for consistency with Abbott policies and guidelines
  - Participate in the regulatory strategy (Variation / Deficiency letters)
  - Management of the Technical Transfers – Quality Part (from Abbott Plants to TPM or from TPM to another TPM)
  - Support resolution of (critical) issues according to internal rules
  - Team Member for global production transfer between plants of the company
  - Team Member in the Product Work stream and participation of strategic decisions
  

• Abbott Healthcare SAS - Regulatory Compliance & Quality System, Deputy Responsible Pharmacist (QP)

  2008 - 2013 - Deputy Responsible Pharmacist – Qualified Person
  - Management of Global Quality Systems used by the plant
  - Insure the regulatory and GMP compliance for the plant
  - Management of the Change Request Process
  - Management of the Quality Risk Management
  - Relationship with French Health authorities for all regulatory data of the plant (Site Master File, Annual Narcotic submission, Pharmacist inscriptions, GMP Certificate, …)
  - Team Member for global production transfer between plants of the company
  - Team Member as Global Operational Quality Assurance during global meeting
  - Write / Review and Approve CMC documents impacting the Abbott Chatillon plant
  - Management of the Local IT validation
  - Maintain regulatory agreement (AFSSAPS, FDA, …) and external customer
  - Participation to regulatory inspections:
  - Presentation of Quality systems and process,
  - Management of the Back-room during inspections/audits and in particular during FDA inspection
  

• Pierre Fabre - QA CMO Manager & QA Project Manager

  Castres 2005 - 2008 - Management of the product switch :
  o Contribution to the definition of the product status (Medicinal Product, Medical Device, Cosmetic product, …),
  o Coordination of all stakeholder for the development of a new project :
  - Marketing Department / Research Department/ Sale and Logistic Department / QA Department
  - Corporate Quality Assurance System
  - Creation of all the QMS documentation for a new entity (specialized in Medicinal Product) in conformity with ISO 13485:2004
  - Participation in the elaboration of Product Development Generic Process.
  - Certification of Third Party Manufacturers (Pharmaceutical / Cosmetic / Medical Device) for PFM (30/35 TPM worldwide)
  - Management of external audits (10-20 audits)
  - Management and Writing of Quality Agreements with TPMs
  - Management of complaints (internal and external)
  - Participation in regulatory monitoring and updating of the quality policy
  - Management of industrial transfers (production and analytical)
  
  

• Laboratoires Macors - Head of QC

  2003 - 2005 - Management of a group of 20
  - To ensure the optimization of management of staff, of the organization of the department (Data processing, automatization, security…) and of personal development.
  - Relations with scientific department and/or customers, to ensure the scientific support for all the analytic aspects (security, adjustment of method, support of production, validation …).
  

Formations

• Université Lyon 1 Claude Bernard Institut de Pharmacie Industrielle de Lyon

  Lyon 2002 - 2003

• Université Lyon 1 Claude Bernard

  Lyon 1997 - 2003 Option Industrie - Aff Technico Réglementaire

• Ecole Nationale Supérieure De Chimie

  Montpellier 1994 - 1997 Chimie des Polymères

Réseau

• Brigitte RUFFIN

• Didier HOARAU

• Dominique PARIS

• Fabien SILVE

• Hugues BOCCHIALINI

• Marine EUDE

• Marion THOREAU

• Philippe MAS

• Sarah COURONNE - FOUILLET

• Thierry DELEUZE