Director, Quality Assurance
insitroAI-driven Drug company
South San Francisco, United StatesDirector
Andreessen Horowitz
BlackRock
CPP Investments
ARCH Venture Partners
Third Rock Ventures
Two Sigma Ventures
Operations & Strategy
About the role
TL;DR
Lead quality assurance for AI-driven drug discovery at Insitro.
- •The Director of Quality Assurance will lead the quality culture at Insitro, ensuring compliance with regulatory standards for AI-driven drug discovery.
- •Key Responsibilities Design and implement a robust Quality Management System (QMS) Author core Standard Operating Procedures (SOPs) and develop a streamlined training program Provide expert guidance on maintaining compliance for early-phase clinical work Lead the quality lifecycle for CROs/CMO/CDMOs and perform audits for partners Partner with Compute and Data Science teams to establish a framework for the validation of AI/ML models Requirements 10+ years of QA experience in biotech/pharma Expert knowledge of GLP, GCP, and GMP regulations Extensive experience conducting vendor audits and preparing for regulatory inspections Working understanding of Computer System Validation
Required skills
Google CloudCompliance Management
Domain expertise
biotech