Yadira Muniz
About Yadira Muniz
Yadira Muniz is the Associate Director for the Investigation Program Quality System at Bristol-Myers Squibb, where she also serves as Product Compliance Quality Manager and Compliance Specialist.
Current Role at Bristol-Myers Squibb
Yadira Muniz is currently serving as the Associate Director for the Investigation Program Quality System at Bristol-Myers Squibb. In this role, she is responsible for aligning the facility's Quality Systems with GMP's, regulatory standards, and requirements for both domestic and international markets. She also conducts root cause analysis to ensure underlying problems are identified and resolved. Additionally, she leads Field Alert Report/Biological License Application (FAR/BLA) and Recall investigations, implementing necessary actions to comply with regulations and Bristol-Myers Squibb guidelines.
Previous Experience in Compliance
Yadira Muniz has a strong background in compliance, having held various roles at different organizations prior to her current position. She served as a Compliance Specialist at Wyeth Pharmaceuticals from 2007 to 2009 and as a Compliance Associate Manager at Patheon from 2007 to 2008. Her experience in these roles involved assisting with regulatory agency inspections, such as those conducted by FDA, EMEA, COFEPRIS, KFDA, TGA, and ANVISA, as well as internal company audits. She was also responsible for preparing and keeping track of facility performance metrics and deadlines.
Educational Background
Yadira Muniz completed her education at the Polytechnic University of Puerto Rico, where she studied Manufacturing Competitiveness and earned a Master's Degree. Her academic journey spanned from 2010 to 2012, equipping her with the theoretical and practical knowledge necessary for her roles in the pharmaceutical industry.
Responsibilities in Quality Management
In her various roles at Bristol-Myers Squibb, Yadira Muniz is tasked with several key responsibilities. She reviews and approves master documentation related to operational and support areas, ensuring compliance with Standard Operating Procedures (SOPs) and Bristol-Myers Squibb's policies. She provides guidance and support for transferring new products and processes to maintain quality during method transfers. Additionally, Muniz executes and implements both domestic and international regulations and guidelines, making sure the facility meets established requirements.