Senior Director, Quality Assurance

The posting, as insitro wrote it

THE OPPORTUNITY

insitro is a physical AI company dedicated to unlocking causal human biology and accelerating the delivery of better medicines to patients. Our unique Virtual Human™ platform identifies novel, high-impact genetic intervention points, which our TherML™ platform translates into therapeutics—whether small molecules, biologics, or oligos. With multiple programs in metabolic disease and neuroscience advancing toward the clinic, and our first IND submission slated for the second half of this year, we are at a pivotal inflection point.

We are looking for a Senior Director of Quality Assurance to build a pragmatic, inspection-ready quality function for clinical-stage operations. You will own insitro's approach to GMP and GCP quality, clinical data quality oversight, and data integrity, at the intersection of outsourced development, clinical execution, and AI-enabled R&D. This is a senior individual contributor role, with growth opportunities as our pipeline grows. You will be personally accountable for building insitro’s Quality systems: standing up our QMS and SOPs, overseeing or conducting vendor/site audits, while serving as the company's quality voice with executives, partners, and the board.

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

Quality Management System

• Own the Operating System: Lead the evolution of insitro's QMS beyond initial setup into an active, effective system
• Build and Scale Core Processes: Mature CAPA, deviations, change control, training, and document management to support organizational growth
• Author the Standards: Write, revise, and implement SOPs, policies, and quality workflows as the business requires

GXP Oversight & Vendor Quality

• Qualify and Audit Partners: Own qualification, audits, and quality agreements across CDMOs, CROs, and investigator sites
• Facilitate GMP Release: Provide hands-on oversight of product release, batch record review, stability programs, and annual product reviews through Phase 2 in partnership with CMC
• Own Clinical Quality: Lead TMF quality, clinical audit planning, and sponsor oversight activities in partnership with clinical operations and data management
• Drive Inspection Readiness: Prepare the organization for pre-IND, IND, and BIMO milestones and lead sponsor-side response to findings

Data Integrity & AI-Enabled Workflows

• Set the Data Integrity Bar: Define expectations for documentation, traceability, review, and change control from raw biological data through clinical insight
• System and Data Validation: Partner with Compute and Data Science on model documentation, change control, and validation approaches for clinical applications of AI/ML outputs informing patient selection, biomarker selection, and trial design
• Manage Continuous Change: Develop phase-appr

[…]
provides transport to and from our South San Francisco HQ from locations all around the Bay Area

insitro is an equal opportunity employer. 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 http://insitro.com, and if in doubt, contact us at info@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 http://www.insitro.com.