Kerry Joshi

Background

About Kerry Joshi

I am a hands-on Quality leader focused on phase-appropriate, collaborative and practical solutions. I bring extensive background from pre-clinical through commercial operations and from biotech startup through large pharma. My experience is across a range of modalities including cell and gene therapy, combination products, mRNA, vaccines, large molecule, and covering project management, building quality systems, facility commissioning/qualification, tech transfer, validation, inspection readiness, GMP manufacturing, and contract manufacturing/testing oversight. I have CMC regulatory experience including successful IND, BLA and through FDA Pre-Approval Inspection. I value strong cross-functional partnerships, and I enjoy building high-performing teams and successful, audit-ready quality programs.