Vivianne J. Arencibia

Arencibia Quality Compliance Associates
Independent Consultant
Vivianne Arencibia is President of Arencibia Quality and Compliance Associates, LLC based in the Northeast. She a brings over 30 years of global leadership, regulatory remediation and compliance experience to the ISPE community. Her prior experience was with Novartis, where she held a variety of leadership positions, most recently as the Global Head of External Engagement for Group Quality at Novartis. Since assuming this role in 2017, Vivianne is responsible for the strategic global engagement plan for GxP related matters across trade, member-based and standards setting organizations. Vivianne joined Novartis in 1997 as a QA Manager in Manufacturing and has since then assumed leadership positions of increasing responsibility across multiple GxP disciplines. Following her initial appointment, Vivianne served as Global Head of Clinical Quality Assurance, Development; Global Head Group Quality Compliance and Audit; and Global Head, Step Change, Integrity and Compliance. Throughout her tenure with the Novartis, Vivianne developed strong relationships with industry associations, trade organizations and regulators, worldwide. Vivianne has been a dedicated ISPE member since 1991. She is currently a member of the RQHC North America Regional Focus Group, Women in Pharma and GPMLF. Within Novartis, Vivianne provided strong advocacy for ISPE and participated in activities such as planning committees for ISPE meetings and as a speaker on industry current topics. She has sponsored Novartis involvement on the Quality Metrics ISPE working group and ISPE’s Young Professionals program. Vivianne is passionate about the development and mentoring of future industry leaders and as such is a strong advocate for ISPE’s efforts within Novartis and among industry peers. Additionally, Vivianne facilitated the coordination of financial and conference sponsorships for over 400 ISPE members employed by Novartis. Vivianne holds a Bachelor’s degree in biomedical engineering from the New Jersey Institute of Technology and has completed several business and leadership development programs at Harvard University, Dartmouth University, and at Bürgenstock, Switzerland.