Shivakumar Shankar

Shivakumar Shankar has extensive experience in the field of IT applications and computer systems validation. Shivakumar is currently working as the Director - IT Applications at Vir Biotechnology, Inc., where they lead the selection, implementation, and maintenance of corporate IT GxP applications. Shivakumar also provides technology leadership and ensures compliance with established GxP policies and procedures.

Prior to their current role, Shivakumar worked at Jazz Pharmaceuticals as an Associate Director IT Computer Systems Validation and IT Risk Management. Shivakumar was responsible for managing security and compliance activities, defending internal and external audits, and authoring vendor assessments for IT GxP systems.

Shivakumar has also held positions at Gilead Sciences as a Principal Validation Consultant, where they managed the validation of projects and delivered impact assessments on enhancement changes. At GE Healthcare, they worked as a Validation Manager, overseeing validation activities for GxP critical computer systems. Shivakumar also worked at Genentech, Medtronic, Inc., Kyphon Inc., and Millennium InfoTech in various validation and quality engineering roles.

Overall, Shivakumar brings a wealth of experience in IT applications, computer systems validation, and compliance with GxP regulations.

Shivakumar Shankar holds an Executive-MBA degree in Strategy from the Indian Institute of Management, Lucknow, which they obtained in 2012. Shivakumar also has a Master of Science (MS) degree in Mechanical Engineering from the New Jersey Institute of Technology, earned in 2003. Prior to that, they completed their Bachelor of Engineering (B.E.) in Mechanical Engineering from Bangalore University between 1997 and 2001. In addition to their formal education, Shivakumar has obtained several certifications, including Business Analysis Foundations: Business Process Modeling and Enterprise Architecture Foundations from LinkedIn, Certified Information Systems Auditor® (CISA) from ISACA, Transitioning from Waterfall to Agile Project Management from LinkedIn, and Inspiring Leadership through Emotional Intelligence from Coursera Verified Certificates.