Santosh Tharkude
Director, Technology, Quality and Regulatory Compliance, Johnson & Johnson
I work in Johnson & Johnson Technology Quality & Regulatory Compliance group. My team is responsible for GxP regulatory compliance strategy and operational excellence in support of J&J’s Technology Services team, including J&J Data Center Inspection Readiness, direct support to business segments during Health Authority and other Third-Party audits related to Technology areas, ensuring that our QMS is current with external regulatory environments through the Standards Management program, providing leadership for the Internal Audit, Supplier Audit, and GxP System Periodic Review programs, and providing compliance expertise for several emerging technologies as well as new acquisitions/divestitures.
I have over 20 years of regulatory compliance experience in the biotechnology and pharmaceutical industries, with a solid foundation of IT skills, understanding of IT frameworks, several years of experience as an IT auditor, experience in GxP regulations, Computer Systems Validation (CSV) and in managing several Health Agency inspections.
- I am a Certified Information Systems Auditor (CISA) (certification obtained from ISACA).
- I am also a certified Data Center Infrastructure Specialist (DCIS) (Certification provided by IDCA).
- I graduated from Rutgers University, NJ with a Master of Science degree in Industrial & Systems Engineering, and a Bachelor of Science degree in Mechanical Engineering from University of Pune, India.
