Mario Jedra
Sr. Director, GMP/GDP Auditing at Bristol-Myers Squibb
- Role
- Sr Director, Gmp Gdp Auditing at Bristol Myers Squibb
- Location
- South Bound Brook, NJ, US
- LinkedIn followers
- 500 followers
About Mario Jedra
Over 20 years of experience in the pharmaceutical, biotech, and IT industries, with management leadership expertise in regulatory compliance, enterprise risk management, analytics and business intelligence, auditing, quality assurance, computer systems validation (CSV), information technology (IT), and Cellular Therapy (CAR-T). Experience includes assessments of enterprise-level processes and business entities for compliance with internal quality standards as well as regulatory guidelines/requirements including FDA\\EU Data Integrity, SOX, GDPR, GAMP 5, PIC/S, Eudralex, and 21 CFR Part(s) 11, 210, 211, and 820.
Experience
Sr Director, Gmp Gdp Auditing
Feb 2020 — Present · Summit, NJ, US
Responsible for all GMP/GDP audits globally inclusive of BMS internal processes and in-market sites as well as external vendors and GxP product/service providers, while managing an organization of ~30 reports- Ensure transformational change via breakthrough innovation inclusive of design and implementation of a risk-based approach to audit planning (500 audits annually), execution, and follow-up- Provide health authority inspection support inclusive of official responses to 483s- Support the implementation of an enterprise-level global audit management system while ensuring process alignment with system functionality- Ensure cross-audit collaboration across GxP audit functions as well as identification, communication, and mitigation of risks across the company- Ensure design and implementation of effective risk management via development of KPIs to enable value-added decision making.
Education
Penn State University
BS, Computer Engineering
1996 — 2001
Penn State University
MBA
2005 — 2007
Rutgers University
Lean Six Sigma Black Belt
2007 — 2007
MIT Sloan School of Management
Executive Management
2010 — 2012
Skills
- Quality Management
- Software Documentation
- Quality Assurance
- Process Improvement
- Validation
- Pharmaceutical Industry
- Sop
- Fda
- Computer System Validation
- Capa
- Quality System
- V&V
- Gmp
- Change Control
- 21 Cfr Part 11
- Gxp
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