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Salary: USD 273,000 - 290,000 / annual
insitro is a physical AI company using machine learning and cellular/cohort data to decode biology and accelerate drug discovery. The company is advancing multiple programs in metabolic disease and neuroscience toward the clinic, with an IND submission planned for late 2026.
You will build and lead insitro's quality assurance function as it transitions to clinical-stage operations. This is a senior individual contributor role reporting to the Chief Technology Operations Officer, with growth opportunities as the pipeline expands. You will own the company's Quality Management System (QMS), GMP/GCP compliance, clinical data quality, and data integrity across outsourced development, clinical execution, and AI-enabled R&D.
Key responsibilities include:
**Quality Management System:** Lead the evolution of the QMS beyond initial setup into an active, effective operating system. Build and scale core processes including CAPA, deviations, change control, training, and document management. Author SOPs, policies, and quality workflows as business needs evolve.
**GXP Oversight & Vendor Quality:** Qualify and audit partners across CDMOs, CROs, and investigator sites. Provide hands-on oversight of product release, batch record review, stability programs, and annual product reviews through Phase 2. Lead TMF quality, clinical audit planning, and sponsor oversight. Prepare the organization for pre-IND, IND, and BIMO milestones and lead sponsor-side responses to regulatory findings.
**Data Integrity & AI-Enabled Workflows:** Define expectations for documentation, traceability, review, and change control from raw biological data through clinical insight. Partner with Compute and Data Science teams on model documentation, change control, and validation for clinical AI/ML applications. Develop phase-appropriate approaches to model drift and evolving algorithms that withstand regulatory scrutiny.
**Executive & Cross-Functional Leadership:** Contribute quality and data integrity context to partnership and diligence conversations. Build credibility across research, clinical, regulatory, CMC, and data science teams to integrate quality into workflows and development approaches.
The role is based in South San Francisco with a hybrid schedule of either three days per week or one full week per month.
**Requirements:**
- 12+ years in pharma or biotech quality with progression into senior QA leadership
- Track record advancing a molecule from preclinical development through IND and into Phase 2 or beyond in a resource-constrained environment with substantial outsourced execution
- Deep expertise in either GMP or GCP with genuine working competence in the other
- Hands-on experience configuring or materially building a QMS (ZenQMS, Veeva Vault QMS, Qualio, MasterControl, TrackWise, or similar)
- Strong grounding in data integrity and computer system validation fundamentals, including ALCOA+, 21 CFR Part 11, GAMP 5 categorization, and audit trail review
- Participation in sponsor-side FDA GMP or BIMO inspection
- Familiarity with how regulators approach AI/ML in regulated environments and ability to reason about emerging expectations
- Familiarity with AI/ML applications in discovery, biomarker selection, dose selection, or trial design
- Ability to serve as the quality voice in a room of ML engineers and data scientists without being an ML expert
- Risk-based, pragmatic approach to building fit-for-stage processes
- Hands-on operator mentality with willingness to write SOPs, conduct audits, and stand up systems
- Strong cross-functional communication skills for quality and data integrity posture to non-quality audiences
