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Eric MARCHESE

Marly-le-Roi

En résumé

My objective is to lead the implementation of lean and efficient quality management systems in international life sciences companies.

I am a Quality Assurance professional with experience in R&D, Product Development, Manufacturing and Quality Control in small and large international pharmaceutical companies - Strategic thinking, pragmatic & results oriented.

Specialties:
- Classical pharmaceutical and biotech manufacturing, distribution and supply chain processes
- Practical experience in implementing quality management systems in Switzerland and in European countries
- Implementation and roll-out of electronic Quality Systems (TrackWise, SAP, FirstDoc, SumTotal, ZincMaps, Valgenesis)
- Computerized systems compliance (CSV, GAMP5)
- Implementation of continuous improvement programs using Lean-Sigma principles
- GMP Compliance auditing
- Project Management
- Leading global and multi-cultural teams

Mes compétences :
Training
Cell culture
Lean manufacturing
Risk management
Quality Assurance
GMP
Audit
QA
GXP
Assurance qualité
Management de la qualité
Qualité
Sciences de la vie

Entreprises

  • GlaxoSmithKline - R&D Integration Consultant

    Marly-le-Roi 2017 - maintenant
  • Alexion Pharmaceuticals - Director Quality Systems, Corporate Quality and Compliance

    Courcouronnes 2012 - 2017 Lead programs for the development and implementation of global GXP Quality Policies, Quality Standards and Quality Systems.
    Lead the development and implementation of global GXP electronic Quality Systems.
  • Alexion Pharmaceuticals - Senior Manager, Quality Systems

    Courcouronnes 2009 - 2012 Responsible for the development and maintenance of global Quality Systems to support Alexion GMP/GDP operations.
  • Merck Serono - Head of Quality Systems and Programs

    Lyon 2009 - 2009 Responsible for the definition of Merck Serono Governance (i.e. Standards, Guidelines) in order to ensure Quality and compliance of the Business processes
    Responsible for the definition and maintenance of global standardized electronic quality systems (e.g.: ERP systems, TrackWise, Document management systems)
    Ensure qualification and validation of global computerized systems across Merck Serono Tech Ops
    Design and manage the yearly audit and inspection program for MS Tech Ops
    Design the Compliance Improvement and Effectiveness Program (e.g.: KPI), to ensure periodic reporting to management and to provide recommendations for improvements
    Manage a team of 6 people
  • Merck Serono - Associate Director Quality Management ERP Systems

    Lyon 2009 - 2009 • Responsible for supporting all Merck sites worldwide for the implementation and roll out of SAP QM module.
    • Responsible for the definition and maintenance of global harmonized processes and data in compliance with Health Authorities requirements
    • Accountable for the quality and compliance of the business processes managed with Merck KGaA ERP systems
    • Manage a team of 4 people
  • Merck Serono - Sr Manager Quality Management, Biotech Manufacturing & Process Development

    Lyon 2008 - 2008 Responsible for supporting all Merck Serono Biotech sites including medical devices (8 locations) on all quality related aspects.
    Provided coaching and training in the implementation of company quality systems and standards
    Supported the sites heads of quality (QC & QA) in the management of changes, deviations, audits and critical quality issues
  • Serono - Sr Manager Quality Systems, Corporate Quality Assurance

    2000 - 2008
  • Serono - Documentation Development Specialist

    1998 - 1999 Team Leader for the development of an Electronic Documents Management System (EDMS).
    Lead a project to reduce the number of procedures in the Plant. After one year a 30% reduction was achieved.
  • Serono - Head of Laboratory

    1990 - 1998 Head of Purification and In-Process Control Laboratory

    Developed and validated purification processes for the production in bioreactors of recombinant proteins produced by mammalian cells.
    Transferred processes and methods from/to USA, Italy, and Israel.
    Developed and validated In-process control (IPC) tests for the monitoring of bioreactors.
    Managed a team of 5 laboratory Technicians.
  • Sanofi - Research Scientist

    Paris 1984 - 1990 Research Scientist, Protein Biochemistry

    Developed purification processes and characterized recombinant proteins (cytokines) expressed in mammalian cell lines and in bacteria.
    Developed and Managed the cell culture laboratory for routine testing of cytokines activities (IL-1, IL-2, IL-6) and development of biological assays in order to identify new proteins involved in the regulation of the immune system.
    Responsible or the operation of a flow cytometer (FACScan).
    Managed a team of 2 laboratory Technicians and 1 Ph.D. Student

Formations

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