Vivianne J. Arencibia

Vivianne Arencibia is Global Head and Vice President of Compliance, Risk Management, and Audit at Lonza, where she leads the global strategy for quality governance, enterprise risk management, and regulatory compliance across a multinational CDMO network. She brings more than 30 years of global leadership experience spanning quality systems, regulatory remediation, audit, manufacturing, and development in highly regulated environments. Prior to Lonza, Vivianne served as Vice President of Global Quality Systems and Compliance at Moderna. She also founded Arencibia Quality & Compliance Associates, advising organizations on quality transformation and regulatory strategy. Earlier, she spent over two decades at Novartis, holding senior leadership roles including Global Head of Clinical Quality Assurance, Global Head of Group Quality Compliance and Audit, and Global Head of External Engagement for Group Quality, where she shaped enterprise-wide GxP strategy and global regulatory engagement. Vivianne has been an active leader within ISPE since 1991 and currently serves as Chair of the ISPE International Board of Directors. She is a strong advocate for industry collaboration, regulatory alignment, and the development of future leaders in quality and compliance. She holds a Bachelor’s degree in Biomedical Engineering from the New Jersey Institute of Technology and a Master of Jurisprudence in Pharmaceutical and Medical Device Compliance from Seton Hall Law School, and has completed executive leadership programs at Harvard, Dartmouth, and Bürgenstock, Switzerland.