The Opportunity

As we transition into clinical-stage operations, we are looking for a Director of Quality Assurance to serve as a key architect of our quality culture. This is a "player-coach" role designed for a leader who can balance rigorous GXP compliance with the agility required in a data-driven, AI-forward company. You will stand up our clinical quality systems, manage global vendors, and partner with our Compute organization to define how the next generation of AI-driven medicine is validated and regulated.

Based in South San Francisco, this position reports directly to the Chief Technology Operations Officer and offers an in person hybrid schedule of either three days per week or one full week per month.

Responsibilities

• Clinical Quality & QMS Leadership
  
  • Build the Foundation: Design and implement a robust, phase-appropriate Quality Management System (QMS), including Document Control, Deviations, CAPAs, and Change Control
  • SOPs & Training: Author core SOPs and develop a streamlined training program that ensures compliance without creating unnecessary friction for the research and operations teams
  • Phase-Appropriate Strategy: Provide expert guidance on maintaining compliance for early-phase clinical work while building a scalable bridge toward future commercialization
  • Vendor Oversight: Lead the quality lifecycle for CROs/CMO/CDMOs. Perform audits for partners performing GLP, GCP, and GMP work to ensure they meet our internal and regulatory standards
  
  AI/ML & Computational Quality Partnership
  
  • Algorithmic Integrity: Partner with the Compute and Data Science teams to establish a framework for the validation of AI/ML models used in patient selection, biomarker discovery, or clinical endpoint analysis
  • Data Lineage & Governance: Collaborate with data engineers to ensure end-to-end traceability and data integrity-from raw biological data to final clinical insights
  • Continuous Validation: Develop "phase-appropriate" monitoring for evolving algorithms to manage and document model drift in a regulatory-friendly manner
  • Tech-Stack Qualification: Support the qualification of cloud-based compute environments to ensure they meet data storage and processing requirements for managing clinical data
  
  Strategic Operations & Risk Management
  
  • Business Risk Oversight: Establish quality systems for research operations and business risk to protect the company's intellectual and physical assets
  • Stakeholder Partnership: Partner with diverse teams-from bench scientists to machine learning engineers-to demystify compliance and integrate quality into the daily workflow
  • Sounding Board: Serve as a primary advisor to leadership, providing clear direction to ensure the company remains compliant with FDA, EMA, and global regulations

About You

• Experience & Qualifications:
  
  • Proven Tenure: 10+ years of QA experience in biotech/pharma, with a track record of moving a small company through clinical entry
  • GXP Mastery: Expert knowledge of GLP, GCP, and GMP regulations
  • Audit Experience: Extensive experience conducting vendor audits and preparing for regulatory inspections
  • Tech Literacy: Working understanding of Computer System Validation and a comfort level discussing data pipelines and controls with software and IT engineers
  
  Core Competencies:
  
  • Hands-on Builder: You are not afraid to "roll up your sleeves" to write an SOP or file a report, while still maintaining the strategic vision of a department head
  • Comfort in Ambiguity: You thrive in the "build" phase and can create processes where none exists
  • Pragmatic Mindset: You understand that "one size does not fit all" and can tailor quality solutions to the company's specific size and stage of development
  • Collaborative Influence: Ability to provide firm compliance direction while remaining a supportive partner to internal technical and scientific stakeholders

Compensation & Benefits at insitro

Our target starting salary for successful US-based applicants for this role is $205,000 - $218,000. To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data.

This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and our Equity Incentive Plan, subject to the terms of those plans and associated policies.

In addition, insitro also provides our employees:

• 401(k) plan with employer matching for contributions
• Excellent medical, dental, and vision coverage as well as mental health and well-being support
• Open, flexible vacation policy
• Paid parental leave of at least 16 weeks to support parents who give birth, and 10 weeks for a new parent (inclusive of birth, adoption, fostering, etc)
• Quarterly budget for books and online courses for self-development
• Support to attend professional conferences that are meaningful to your career growth and role's responsibilities
• New hire stipend for home office setup
• Monthly cell phone & internet stipend
• Access to free onsite baristas and daily lunch for employees who are either onsite or hybrid
• Access to a free commuter bus network that provides transport to and from our South San Francisco HQ from locations all around the Bay Area

#LI-Hybrid

Please be aware of recruitment scams: we never request payments, all recruitment communications are from @insitro.com, and if in doubt, contact us at [email protected].