Manoj Kumar Sahu

Background

About Manoj Kumar Sahu

Accomplished senior Quality leader with a proven track record spanning over two decades in the pharmaceutical industry, specializing in Biopharmaceutical, Pharmaceutical, Vaccines drug substance, and drug product manufacturing. Recognized for my strategic leadership, I have successfully steered Quality Assurance, Quality Control, Regulatory, and EHS functions to achieve excellence. My extensive experience encompasses the management of a diverse range of products, including sterile injectables, oral dosage forms, active pharmaceutical ingredients, and Human vaccines. I am adept at leading the transformation of Quality systems to meet and exceed rigorous international standards, consistently ensuring compliance with regulatory authorities such as USFDA, EMA, WHO, ANVISA, TGA, MHRA, SAHPRA, ISO, DCGI, and other Ministry of Health audits for ROW countries. As a visionary in digital transformation, I have implemented cutting-edge tools and modules, establishing sustainable and robust processes. My expertise in QMS, Validation, Technology transfer, project management extends to successfully overseeing both greenfield and brownfield projects, emphasizing compliance with international standards and qualifying multiple Injectable lines. In my role as a strategic Quality leader, I excel in aligning Quality functions with overarching business objectives and serve as a trusted single point of contact for Senior Management. Known for effective team management, I mentor and lead cross-functional teams, fostering collaboration and delivering exceptional results in various therapeutic areas within the pharmaceutical and biotechnology industry.