Andrew Kalungi
Quality Systems Manager @Reata Pharmaceuticals, Inc
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WORK HISTORY
Quality Systems Manager @Reata Pharmaceuticals, Inc
Plano, TX, US
Championed the hands-on implementation and continuous improvement of the company\'s Quality Management System (QMS), ensuring full compliance with regulatory requirements across the entire product lifecycle from development to global commercialization. My collaborative approach with internal teams fortifies clinical IND and commercial product programs, bolstering the organization\'s quality objectives and operational excellence.
EDUCATION
United States International University - Africa
Bachelor of Science (B.S.), Information Systems and Technology
Boston University
Master's degree, Computer Information Systems
SKILLS
ABOUT ANDREW KALUNGI
Clinical manufacturing expert with 9+ years in Quality Systems Management. Proven track record in strategic validation activities, system administration, application development, and continual process improvement. Proficient in regulatory compliance, CAPA initiatives, and GxP environment.CORE COMPETENCIESQuality Systems Management • IT Validation • Good Practice (GxP) Regulatory Compliance • System Development • Root Cause Analysis • Risk Mitigation • Corrective and Preventative Actions (CAPA) • Project Management • SAP Quality Management (QM) • LIMS
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