Shivakumar Shankar serves as the Director of IT R&D Applications at Mirum Pharmaceuticals, Inc., where he plays a pivotal role in ensuring that the company’s IT systems and processes adhere to stringent GxP regulations and comply with FDA and EU standards. With a sharp focus...
Shivakumar Shankar serves as the Director of IT R&D Applications at Mirum Pharmaceuticals, Inc., where he plays a pivotal role in ensuring that the company’s IT systems and processes adhere to stringent GxP regulations and comply with FDA and EU standards. With a sharp focus on IT Security and Compliance, Shivakumar leverages his extensive experience in the biotech and medical sectors to oversee critical aspects of IT operations, including the management of Standard Operating Procedures (SOPs), validation processes, and data integrity initiatives. His expertise in IT Risk Management and Quality Auditing is instrumental in maintaining the integrity and security of R&D applications that support the company’s innovative research initiatives.
In his current role, Shivakumar is not only responsible for vendor qualifications and management but also for the strategic oversight of IT applications that drive R&D business functions. His proficiency in Agile Project Management allows him to lead cross-functional teams effectively, ensuring that projects are delivered on time and within budget while meeting the highest quality standards. Additionally, his strong background in Enterprise Architecture enables him to align IT strategies with organizational goals, fostering a culture of compliance and operational excellence.
Shivakumar's commitment to continuous improvement and his detail-oriented approach have made him a key player in Mirum Pharmaceuticals' mission to advance therapeutic solutions. His ability to navigate complex regulatory landscapes while managing diverse IT operations positions him as a trusted leader in the life sciences industry, dedicated to driving innovation through robust IT governance and compliance frameworks.
