Marleny Gomez, MBA
About Marleny Gomez, MBA
Marleny Gomez, MBA, is the Manager QA for the Global Supplier Quality Program Management at Bristol Myers Squibb in Summit, New Jersey. She has over twenty years of experience in quality assurance within the pharmaceutical and biotech industries.
Current Role at Bristol Myers Squibb
Marleny Gomez currently holds the position of Manager QA, Global Supplier Quality Program Management at Bristol Myers Squibb in Summit, New Jersey. In this role, she is responsible for overseeing the quality assurance of global supplier programs, ensuring compliance with industry standards and regulations. Her tasks include managing supplier deviations and coordinating supplier change notifications. She is also involved in providing quality support to stakeholders and subject matter experts.
Previous Roles in Quality Assurance
Marleny Gomez has extensive experience in quality assurance, having worked in various capacities across multiple organizations. She served as Sr. Specialist, CTDO-External QA CAR T at Bristol Myers Squibb from 2019 to 2021 and as External QA, CAR T at Celgene from 2018 to 2019. Prior to that, she worked at Akorn, Inc as Senior Associate QA Investigations/CAPA from 2016 to 2018. At Pfizer, she held several roles, including Sr Associate QA from 2012 to 2016, Quality Assurance Specialist from 2003 to 2012, and External Supply Quality Assurance Team Leader from 2001 to 2003. Her career in quality assurance began at PAR Pharmaceutical, Inc, where she worked as Quality Assurance Inspector from 1987 to 1997.
Educational Background
Marleny Gomez earned her Master of Business Administration (MBA) in Business Administration and Management from Iona College, Hagan School of Business, where she studied from 2007 to 2011. She also holds a Bachelor of Science (BS) degree in Materials Management from Bloomfield College, completed between 2000 and 2005. Her academic background has equipped her with the foundational knowledge necessary for her roles in quality assurance and management.
Expertise in CAR T Products
Marleny Gomez has a comprehensive background in managing quality assurance for CAR T products, a type of immunotherapy used in cancer treatment. Her experience in this area includes roles at both Bristol Myers Squibb and Celgene, where she was involved in ensuring the quality and compliance of these innovative therapies. Her expertise in CAR T products positions her as a knowledgeable professional in the field of cancer immunotherapy.
Skills in Quality Systems and Standards
Marleny Gomez possesses extensive knowledge of various quality systems, including SAP, LIMS, PDOCS, and QTS. She is well-versed in international current Good Manufacturing Practices (cGMPs), International Council for Harmonisation (ICH) guidelines, and pharmacopoeias such as USP, EP, and JP. Her expertise in these areas enables her to ensure that quality assurance processes meet the highest standards of regulatory compliance and operational efficiency.