Vivianne_Arencibia

Ms. Vivianne J. Arencibia

Vice President, Global Quality Systems and Compliance, Moderna

Vivianne Arencibia is the Vice President of Global Quality Systems and Compliance with Moderna Therapuetics, Inc. based out of Norwood, Massachusetts. She brings over 30 years of global leadership, regulatory remediation and compliance experience to the ISPE community. Prior to joining Moderna Tx, Vivianne lead her consulting company, Arencibia Quality and Compliance Associates, LLC based in the Northeast and before that she held a variety of leadership positions at Novartis AG, most recently as the Global Head of External Engagement for Group Quality at Novartis. Since assuming that role in 2017, Vivianne was 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 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 career, 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 Director on the ISPE International Board of Directors as well as on ISPE Foundation Board. She is the 2022 Governance Officer for the Foundation, is a member the RQHC North America Regional Focus Group and the co-chair for ISPE's International's Women in Pharma Community of Practice. Vivianne provides strong advocacy for ISPE and has participated in planning committees for ISPE meetings and as a speaker on industry current topics. Vivianne is passionate about the development and mentoring of future industry leaders and as such is a strong advocate for ISPE’s efforts among industry peers. Vivianne holds a Bachelor’s degree in biomedical engineering from the New Jersey Institute of Technology, and a Masters of Jurisprudence in Pharmaceutical-Medical Device and Healthcare Compliance from Setion Hall Law School, and has completed several business and leadership development programs at Harvard University, Dartmouth University, and at Bürgenstock, Switzerland.

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