About Our Consulting Expertise

Priti Patel is a Senior Quality Leader and the Founder of Stem11Consulting with over 25+ years of experience building and scaling phase-appropriate quality systems across the biotech, biologics, diagnostics, and cell and gene therapy sectors.

Through STEM11Consulting, LLC, Priti serves multiple roles as a Head of QA as well as Senior QA Consultant, partnering with companies globally to support GXP compliance in product development from Phase 1 through commercial launch within GMP, GCP, and GLP environments. Throughout her career, she has acted as a serial QA function-builder for more than 30+ organizations—including Bristol Myers Squibb, Wyeth (Pfizer), Shire Pharma (Takeda), Landmark Bio, Jounce Therapeutics, CRISPR Therapeutics, Foundation Medicine, Rhythm Pharmaceuticals, Ultragenyx and many others. Priti has also successfully established and supported FDA-compliant quality infrastructures, managed mock PAI and BIMO inspection readiness programs leading up to hosting FDA and other Regulatory Inspections. Priti has also led critical Part 11 eQMS implementations/validation for platforms such as Veeva Vault, ZenQMS, Qualio, and MasterControl. Her strategic expertise spans across GxP compliance, comprehensive vendor oversight, Clinical/CMC quality assurance, and cross-functional collaboration to ensure sustainable quality operations.

Beyond her consulting work, Priti serves as a Voluntary Institutional Review Board (IRB) Member at the Harvard T.H. Chan School of Public Health, reviewing research protocols to protect human subjects. She holds a Bachelor of Science in Biotechnology from the University of Massachusetts Lowell, maintains an active ASQ-CQA certification, and is currently pursuing a PhD in Quality Assurance and Regulatory Affairs at Temple University.