Shivakumar Shankar
About Shivakumar Shankar
Shivakumar Shankar is a Director of IT R&D Applications at Mirum Pharmaceuticals, Inc., with a robust background in IT validation and compliance across various biotech and medical device companies. He holds an Executive MBA from the Indian Institute of Management, Lucknow, and has extensive experience in managing IT audits, CSV projects, and business continuity strategies.
Current Role at Mirum Pharmaceuticals
Shivakumar Shankar currently serves as the Director of IT R&D Applications at Mirum Pharmaceuticals, Inc. since 2024. His role is based in Foster City, California, and operates in a hybrid work environment. In this position, he is responsible for ensuring compliance with the Drug Supply Chain Security Act (DSCSA) and the European Falsified Medicines Directive (EUFMD) regulations. He collaborates with various R&D business functions, including Quality Regulatory, Clinical, Biometrics, Manufacturing and Supply Chain, and Pharmacovigilance, to enhance automation and optimize systems.
Professional Experience in Biotechnology and Medical Devices
Shivakumar has extensive experience in the biotechnology and medical devices sectors. He previously worked at Vir Biotechnology, Inc. as the Director of IT Applications from 2021 to 2024. His earlier roles include positions at Genentech, Gilead Sciences, Medtronic, Inc., GE Healthcare, and Kyphon Inc. He has demonstrated expertise in managing IT audits, addressing auditing gaps, and completing Corrective and Preventive Actions (CAPAs) related to system and procedural non-conformance.
Education and Qualifications
Shivakumar holds an Executive MBA in Strategy from the Indian Institute of Management, Lucknow, which he completed from 2011 to 2012. He earned a Master of Science in Mechanical Engineering from the New Jersey Institute of Technology in 2003. Additionally, he obtained a Bachelor of Engineering in Mechanical Engineering from Bangalore University, where he studied from 1997 to 2001.
Expertise in IT Compliance and Quality Assurance
Shivakumar has significant experience in managing IT Computer System Validation (CSV) projects with budgets exceeding $1 million, particularly noted in 2019. He is adept at designing and implementing Business Continuity, Backup/Restore, and Disaster Recovery strategies for IT solutions, ensuring alignment with risk mitigation for Good Practice (GxP), Sarbanes-Oxley (SOX), and other business-critical systems. He regularly collaborates with Quality teams to lead continuous improvement efforts and provide insights on technology trends.
Previous Roles and Contributions
Throughout his career, Shivakumar has held various roles that contributed to his expertise in validation and compliance. He worked as a Senior Validation Consultant at Genentech and Gilead Sciences, and as a Senior Software Quality Engineer at Medtronic, Inc. He also served as a Validation Manager at GE Healthcare and as a QA and Compliance Specialist at Kyphon Inc. His roles have consistently involved synthesizing the Voice of Customer to identify industry best practices and deliver tailored solutions.