THIERRY SAVENAY
Director Corporate Quality Audits, Merck
24 contactsCreation and development of a new Corporate function and team
Scope of the audits:
Pharma, Biotech, Chemical Operations and Liquid Crystal activities .R&D, Clinical operations,company's central functions and External partnership Worldwide
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2005- Corporate Ass.Director GXP Operations External Partners
Serono International Corporate QA audits:
Scope: Worldwide: Biotech Strategic Manufacturing Operations, R&D, Corporate Functions, Central Clinical Operations, Commercial Affiliates, Strategic vendors
2002: Exec. Director, GXP Compliance and Quality Systems departments
Manufacturing sites Janssen-Cilag: France val de Reuil and Portugal Lisboa:
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1997-2002 Sr Manager Corporate Quality Aventis Pharma:
Quality Ops Ext Manufacturing Europe: Sterile, Liquid and Solid Dosage Forms. Development of Third-Party manufacturing partnerships. Tech Transfer, submission of dossiers.
Including in 1999: Direction of cGMP Compliance for the opening of a new pharma manufacturing site in Beijing China
1997 Manager WW QA: Creation of the company Worldwide Quality Assurance Manual and Guidelines. Development of the Corporate Complaint Management System
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MISSIONS:
1997: Fisons, Medical Device Certification (auto injector) by GMed
1996: Valois of America, Marketing/Commercial department: Launch of a Pilot Consumer Division USA, Canada and Mexico.
1995: Glaxowelcome: Review of the “product and material loss assessment system” for cost savings.
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1985 - 1995 Head of the Quality Control:
Marion Merrell Dow and Schwarz Pharma : Chemical plant, R&D, Pilot Plant
Analytical Chemistry and Microbiology (15 people): FDA and ISO 9001certified
Chemist, R&D, Pharmaceutical Chemistry: Development of new APIs
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1984 Servier: Chemist, R&D, Pharmacology: Radioimmunology
1981-1982 Centre d'etudes nucleaires de Saclay: intership in development
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Specialties:International experience in Pharma and Biotech industry Management of Corporate Quality Team Negociation with third parties pharma and chemistry development and manufacturing Quality Management GXP /ISO Compliance Auditing Quality control Development activities