Vivianne Arencibia Novartis

Vivianne has been serving Novartis as the Global Head of Group Quality Compliance & Audit since May 1, 2006, and is responsible for GxP regulatory compliance management (inspection management and regulatory liaison with global Health Authorities) and the GxP audit program (applicable to all Novartis divisions and business units). Vivianne joined Novartis in 1997 in Manufacturing, and subsequently held positions of increasing responsibility in the areas of Manufacturing, Clinical Safety and Epidemiology and Clinical QA.

As the Global Head of Group Quality Compliance & Audit, Vivianne has a successful track record of GxP governance and compliance oversight across all of Novartis. This was accomplished through development of compliance status assessments, ongoing monitoring of quality system effectiveness, global health authority inspection management, detailed compliance and remediation strategies, and providing insightful input to key quality policy actions to drive business decisions. Vivianne is currently involved in helping to advance the “Quality Metrics” initiative, and is energetic about the opportunities that success in this field would bring to the industry. Vivianne holds a degree in Engineering Science, with a specialization in Biomedical Engineering from the New Jersey Institute of Technology.