Virginie Wieter

Virginie Wieter

Principal CS Strategy Lead - Roche PDQA, Roche
 

En poste chez Roche

Précédents : Roche, EQual4, Lilly France

 

    En résumé

    Main Roles - Currently Principal Computerized Systems Strategy Lead in PD Quality organisation at Roche Validation Lead, IT Quality Lead, IT Project Manager, Project Quality Manager for Major IT GxP Projects in big pharma Companies such as Novartis and Eli Lilly- Audit and Risk Management - IT Quality System Management - IT processes and SOP's - GxP electronic records archival processes and projects Areas of expertise: Data Integrity - Quality Strategy oversight and risk management for Clinical Data Management, Biometrics, ePRO, eCOA, apps, big data, real world data, reporting systems, cloud solutions... Quality oversight related to data integrity and technology for GCP studies. * GxP Computer System validation - Establish Validation strategy and review key deliverables - Risk Management throughout lifecyle of the systems (MES, LIMS, Environment Monitoring, Advitium, BO, ETL, BIRST, SFDC, Werum, cyphercloud, EDC, SAS, R package, ePRO, eCOA, G...) - Cloud solutions with PII, PHI, complaint Handling data * IT Quality System Management in the Pharmaceutical Industry ( GxP, CSV, CFR21 Part 11…) * International Quality Forum animation (GxP standards, privacy, ER/ES, vendor management…) * Creation and writing of IT Quality Manual and associated procedures * Quality Metrics Management and Risk Management * IT Vendor and service Provider Audits * Management of internal audit and inspections * Multi-sites Project Team Management * Externalization and implementation of a new service desk – site of 1800 employees – *Transition and communication Plan– Change Management * Project Leader for multiple projects of system retirement and data archiving (GED, medical, GMP) multi-sites USA and Europe * Regulated data archiving process * Operating in a diverse and multicultural environment * Project Team management - contractors recruitment and supervision

Parcours

Co-Founder & Managing Partner

Chez EQual4

De mars 2012 à décembre 2014
 

IT Quality Consultant / IT Project Leader

Chez Lilly France

De janvier 1998 à 2011
• Spécialiste Qualité SI → Management du Système Qualité SI dans l’industrie pharmaceutique (normes BPF, GxP…) → Animation de forums Qualité International (normes GxP, privacy, ER/ES) → Validation des applications pour l’industrie pharmaceutique (MES, LIMS, Advitium, Regulus, BO…) → Rédaction ...
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Compétences

 
  • Business development
  • CFR21 Part 11, GMP, Iso 9001, Privacy, Record Rete
  • Computer System Validation
  • Entreprenariat
  • Gestion de projet
  • Informatique
  • Management

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