Sagar Dandawate
GxP Quality and Compliance Leader | Building Inspection-Ready Digital Ecosystems in Pharma & Biotech
- Role
- Director, IT Quality at Protagonist Therapeutics
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Sagar Dandawate
For 15+ years, I’ve led IT quality and regulatory compliance across pharma and biotech where regulatory rigor and innovation must move together. My role is to make sure they do.I lead enterprise GxP IT Quality governance across the full system lifecycle, building and scaling CSV/CSA programs and leading CSV compliance and system administration teams. I’ve driven global Data Integrity assessments across regulated workstreams aligned with MHRA, PIC/S, and FDA guidance, identifying systemic gaps and strengthening inspection readiness.I specialize in transforming fragmented processes into scalable, audit-ready operating models spanning clinical, laboratory, manufacturing and enterprise wide GxP systems.My foundation includes FDA 21 CFR Part 11, EU Annex 11, GAMP 5, MHRA, PIC/S, and ICH guidance applied in real inspections where outcomes matter.I help life sciences organizations move from reactive compliance to proactive quality engineering.
Experience
Director, IT Quality
Nov 2024 — Present
Education
Wayne State University
Master’s Degree, Biomedical Engineering
2009 — 2011
Skills
- Change Control
- Gxp
- Quality System
- U.s. Title 21 Cfr Part 11 Regulation
- Computer System Validation
- Life Sciences
- Medical Devices
- Tumor Immunology
- Capa
- Biotechnology
- Quality Assurance
- 21 Cfr Part 11
- Software Development Life Cycle (Sdlc)
- Validation
- U.s. Food and Drug Administration (Fda)
- Sdlc
- Regulatory Affairs
- Research
- Pharmaceutical Industry
- Sop
- Fda
- Quality Control
- Gmp
- Corrective and Preventive Action (Capa)
- Standard Operating Procedure (Sop)
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