Frances Cartagena
About Frances Cartagena
Frances Cartagena is a Senior Manager QA Validations at Bristol Myers Squibb in Manati, Puerto Rico, with extensive experience in solid and parenteral manufacturing and packaging.
Company
Frances Cartagena is currently employed at Bristol Myers Squibb, a global biopharmaceutical company. She holds the position of Senior Manager QA Validations at the company's facility in Manati, Puerto Rico. Bristol Myers Squibb is known for its dedication to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases.
Title
Frances Cartagena works as the Senior Manager QA Validations. In this role, she is responsible for overseeing quality assurance validations in both solid and parenteral manufacturing and packaging processes. Her duties include ensuring compliance with regulatory standards and managing validation and change control activities.
Education and Expertise
Frances Cartagena has an MBA in Technology Management from the University of Phoenix, where she studied from 2006 to 2008. She also holds a BS in Chemistry from Universidad Interamericana, completed between 1991 and 1996. Her academic background complements her extensive expertise in quality systems management, regulatory compliance, technology, and product transfer.
Background
Prior to her current role, Frances Cartagena gained valuable experience at several prestigious organizations. At Business Excellence Consulting, she worked as a Senior Consultant for eight years from 2013 to 2021. Before that, she served at Pfizer, initially as an Operational Excellence Specialist from 2007 to 2010 and then as Operational Excellence Lead from 2010 to 2012. She also held a similar role at Wyeth Pharmaceuticals from 2007 to 2010.
Experience in Regulatory Compliance
Frances Cartagena has managed Consent Decree and inspection processes, assisting with audits by US and EU regulatory agencies. She is proficient in handling regulatory documents, including cGMPs, CFRs, USP, EP, NDA, and ANDA. Her substantial background in these areas allows her to effectively navigate regulatory environments and maintain compliance with stringent industry standards.