Mario Jedra
About Mario Jedra
Mario Jedra is the Sr. Director of GMP/GDP Auditing at Bristol-Myers Squibb with over 18 years of experience in the pharmaceutical, biotech, and IT industries.
Current Title at Bristol-Myers Squibb
Mario Jedra is currently serving as the Sr. Director of GMP/GDP Auditing at Bristol-Myers Squibb, based in Summit, NJ. In his role, he is responsible for overseeing good manufacturing practice (GMP) and good distribution practice (GDP) compliance audits. He leverages his extensive experience in regulatory compliance and quality assurance to ensure adherence to relevant standards and guidelines.
Previous Roles at Celgene
Mario Jedra held multiple positions at Celgene over an eight-year period. From 2017 to 2020, he was the Director of Corporate CSV Audit in Summit, NJ. Prior to this, he served as the Associate Director of Corporate CSV Audit from 2014 to 2017 in Berkeley Heights, NJ, and as Sr. Manager, Corporate CSV Audit from 2012 to 2014. Before these roles, he was the Associate Manager, IT Quality Assurance from 2008 to 2012. Across these positions, he was responsible for computer systems validation (CSV) and IT quality assurance.
Professional Experience and Expertise
Mario Jedra has over 18 years of experience in the pharmaceutical, biotech, and IT industries. His expertise includes regulatory compliance, auditing, quality assurance, computer systems validation (CSV), and project management associated with regulated (GxP) systems. He has conducted compliance assessments for various regulatory guidelines, including EU Eudralex, FDA Data Integrity, GDPR, GAMP 5, PIC/S, and 21 CFR Part(s) 11, 210, 211, and 820.
Educational Background
Mario Jedra has an extensive educational background, including attending the Massachusetts Institute of Technology - Sloan School of Management for Executive Management from 2010 to 2012. He achieved his MBA from Penn State University in 2007 and holds a BS in Computer Engineering from the same institution, completed in 2001. Additionally, he earned a Lean Six Sigma Black Belt from Rutgers University in 2007.
Specialization in Lean Six Sigma Methodologies
Mario Jedra is commercially trained as a Lean Six Sigma Black Belt. He specializes in implementing Lean Six Sigma methodologies to improve processes and ensure compliance within regulated systems. His training and expertise in this area contribute significantly to his effectiveness in roles that require stringent adherence to regulatory standards and quality assurance processes.