Nancy Fulginiti

Nancy Fulginiti has over 10 years of experience in various quality management roles in the pharmaceutical industry. Their most recent position was as the VP of Quality at Amring Pharmaceuticals Inc. starting in 2022. Prior to that, they held the same position at CRISPR Therapeutics from 2021 to 2022, where they led the Quality Unit supporting the development and commercialization of CGT products. Nancy has expertise in various quality systems and compliance areas, such as GLP, GCLP, GCP, GVP, GMP, and GTP.

From 2016 to 2020, Nancy worked at Novartis as the Audit Head for Good Tissue Practices, GMP, and Global GxP Audit and CAR-T Compliance. In this role, they managed a team of auditors and supported various quality audits related to internal and external manufacturing, suppliers, and contract manufacturing organizations. Nancy also played a key role in developing audit standards and promoting a strong quality culture within the company.

Prior to their time at Novartis, Nancy served as the Executive Director of Quality for the Americas Region at Sandoz, a Novartis company, from 2012 to 2016. In this position, they managed quality systems and compliance for multiple countries, including Canada, US, Mexico, Brazil, and Argentina. Nancy had responsibilities in areas such as GCP, GMP, GVP, and oversaw inspections and remediation efforts for solid dosage and aseptic processing sites.

Throughout their career, Nancy Fulginiti has demonstrated strong leadership skills and expertise in quality management within the pharmaceutical industry.

Nancy Fulginiti has a Bachelor of Science degree in Clinical Laboratory Science/Medical Technology/Technologist from Thomas Jefferson University, which they obtained from 1982 to 1984. Nancy furthered their education at West Chester University of Pennsylvania, earning a Master of Science degree in Clinical Chemistry from 2000 to 2003. Nancy also holds a Certificate in Strategic Organizational Leadership from Villanova University, completed in 2010, and another Certificate in Project Management from the same institution, obtained from 2009 to 2010. Additionally, they completed LSS Black Belt training at Wyeth/ Rath & Strong in 2009. Prior to their bachelor's degree, Nancy attended Neumann University from 1980 to 1982, focusing on Biochemistry. Nancy has obtained various certifications throughout their career, including being a Certified Tissue Bank Auditor from The Colyn Group Quality Consultants, LLC since September 2017, a Certified Quality Auditor from ASQ - World Headquarters since July 2004, a Certified GMP Investigator from Working Words Inc since May 2002, and a Medical Laboratory Scientist (ASCP-MLS) from the American Society for Clinical Pathology (ASCP) since August 1984.