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
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. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. We believe diversity, equity, and inclusion need to be at the foundation of our culture. We work hard to bring together diverse teams–grounded in a wide range of expertise and life experiences–and work even harder to ensure those teams thrive in inclusive, growth-oriented environments supported by equitable company and team practices. All candidates can expect equitable treatment, respect, and fairness throughout the interview process. #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 atinfo@insitro.com*.*
About insitro
insitro is a drug discovery and development company using machine learning (ML) and data at scale to decode biology for transformative medicines. At the core of insitro’s approach is the convergence of in-house generated multi-modal cellular data and high-content phenotypic human cohort data. We rely on these data to develop ML-driven, predictive disease models that uncover underlying biologic state and elucidate critical drivers of disease. These powerful models rely on extensive biological and computational infrastructure and allow insitro to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of insights and therapeutics in neuroscience and metabolism. Since launching in 2018, insitro has raised over $700 million from top tech, biotech and crossover investors, and from collaborations with pharmaceutical partners. For more information on insitro, please visit www.insitro.com.
