Patricia Guadalupe
About Patricia Guadalupe
Patricia Guadalupe is a Senior Manager I, Regulatory and Compliance at Bristol Myers Squibb, with extensive experience in quality assessment, compliance, and regulatory roles within pharmaceutical organizations.
Title
Patricia Guadalupe serves as the Senior Manager I, Regulatory and Compliance, TSE/IPR, Global Regulatory Sciences (CMC) at Bristol Myers Squibb, based in Lawrenceville, NJ.
Current Role at Bristol Myers Squibb
Patricia Guadalupe is currently working as Senior Manager I, Regulatory and Compliance, TSE/IPR, Global Regulatory Sciences (CMC) in Lawrenceville, NJ for Bristol Myers Squibb. In addition, she holds a Manager role in the same department at their Pennington, NJ location. Her responsibilities include ensuring compliance with cGMP requirements, and company SOPs, as well as managing investigations, deviations, and non-conformances.
Previous Experience
Patricia has a rich career history with diverse roles in regulatory and compliance. She was a Regulatory and Compliance Project Manager (Consultant) at Bristol Myers Squibb in 2018. Prior to that, she worked at Impax Laboratories as Product Assurance Specialist I (LEAD) from 2014 to 2017, and at Ethicon, Inc. as an Engineering Analyst I (Contractor) from 2013 to 2014. From 2008 to 2011, she was a Technical Support Specialist at Alere, Inc. Her longest tenure was at St. Peter's University Hospital, where she worked as a Medical Technologist for 19 years.
Educational Background
Patricia studied Biology/Biological Sciences at Cabrini Medical Center and achieved her Medical Technology certification in 1986. She earned a Bachelor of Science degree in Biology from City University of New York City College in 1985, and an Associate's degree in Biology from New York University in 1981.
Technical Proficiency
Patricia is proficient in various software and systems including GDR database, Trackwise, SAP, Microsoft Office Suite, LIMS, CPAS, Seibel, Mastercontrol, Salesforce.com, and Documentum. She has extensive experience in supervising batch reviewers, quality assessment, compliance, regulatory, and process improvements within pharmaceutical organizations.