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Merle CÉCILE

SAINT-GERMAIN-SUR-L'ARBRES

En résumé

Over 15 years of experience in Quality Assurance (Pharmaceutical Industry)
15 years of experience in Team and project Management
Expertise in GLP Regulated environment and Laboratory audits.
Interest in GCP & Clinical Studies, GLP, Quality Assurance, Audit, Management activities

Mes compétences :
Qualité
Audit
Management
GLP
Bonnes pratiques de laboratoire
GCP

Entreprises

  • Charles River Laboratories - QA Manager

    SAINT-GERMAIN-SUR-L'ARBRES 2016 - maintenant

  • Biocorp - Head of Quality & Regulatory Affairs

    2016 - 2016 Management of Regulatory Affairs, Quality Assurance and Quality Control Laboratory
    ISO 13483, ISO 9001, GMP (Medical Devices)
    Implementation of Quality Management System in R&D activities

  • Nabefabric - Management (co-gerante)

    2013 - 2015 Development and management of the start-up, specialized in stationery creation and production

  • Laboratoires Merck Sharp & Dohme Chibret - Quality Assurance Manager

    2002 - 2013 Established, maintained, and directed the GLP QA program :
    - Ensured compliance to applicable regulations and standards (French GLPs, EU, and OECD guidelines)
    - Managed the internal GLP audits and inspections, evaluation and monitoring of Vendors, Contract Research Organizations, and Licensing-in activities in Europe. Ensured internal Regulatory compliance for Computer systems.
    - Coordinated Regulatory Authority inspections conducted at the site - Grade A successfully obtained.
    - Implemented and maintained QA programs for the regulated Clinical Bio-analysis in Europe.

    In global environment (US/Europe), lead and/or represented QA on departmental and cross-functional projects and committees. Sponsored, participated and implemented global operational efficiency efforts (including Six-sigma projects).

    Managed a team of 10 direct reports: supervision and monitoring of assignments, assessment and guidance, performance management and development plan, planning/prioritization. Managed department functions within budgetary constraints.

    Ensured Regulatory Compliance training of stakeholder functions, provided guidance, and served in committees as an expert on regulatory requirements and compliance issues (GXP, European GPL regulations, FDA GLPs, OECD guidelines).

    Represented Merck externally by participating in the national/international forums related to GXP and regulatory requirements (SoFAQ, BARQA, etc).

  • Laboratoires Merck-Sharp & Dohme Chibret - GLP Coordinator

    2000 - 2002 Managed a small QA team (3 auditors), in charge of bioanalytical and toxicokinetic audits and inspections.
    Coordinated internal and external Good Laboratory Practice audits and inspections in France and Europe (GLP Laboratory, CROs, vendors)
    Responsible of Due-diligence reviews for potential licensing candidates in Europe

  • Laboratoires Merck Sharp & Dohme Chibret - GLP Quality Assurance Auditor

    1998 - 2000 Performed internal and external Good Laboratory Practice audits and inspections in France and Europe (GLP Laboratory, CROs, vendors)

Formations

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