Srivatsa Maddi

I am a seasoned professional with 10+ years of diverse experience in Development Quality Assurance & CMC Regulatory Affairs for New Chemical Entities and Generics APIs, skilled in establishing Quality Management Systems to meet Regulatory standards.
Proficient in implementing Lean Six Sigma methodologies to drive process improvements and enhance operational efficiency in Development Quality Assurance & CMC Regulatory Affairs.
Proactively oversees creation and continuous improvement of event reporting and management processes on a global clinical trial material supply, including the oversight of the case management and regulatory submissions activities.
Excellence in monitoring quality and efficiency across functions to identify trends and opportunities for improvements for effective team utilization and productivity.
An effective communicator with strong relationship management skills with the capability to relate to people at any level of business and management across the globe; possess excellent analytical , negotiation skills and team management skills.
My expertise includes compiling regulatory submission dossiers, managing QMS documents, conducting internal and external audits, and overseeing event reporting, investigation, processes and compliance. I am a Certified ISO Lead Auditor and have a strong track record in driving process improvements and ensuring compliance with standards. I have successfully led a team, implemented Lean and managed various aspects  I am confident that my skills in Quality Management, Compliance, Risk Managements

Master of Science in Organic Chemistry