Senior Director, Quality Assurance

## 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-appropriate approaches to model drift and evolving algorithms that hold up under regulatory scrutiny **Executive & Cross-Functional Leadership** - **Support External Discussions:** Contribute quality and data integrity context to partnership and diligence conversations as needed - **Build Credibility Across Functions:** Partner with research, clinical, regulatory, CMC, and data science teams to integrate quality into workflows, and development approaches ## About You **Experience & Qualifications** - **Proven Tenure:** 12+ years in pharma or biotech quality, with progression into senior QA leadership. - **Small-Company Track Record:** You have advanced a molecule from preclinical development through IND and into Phase 2 or beyond in a resource-constrained environment with substantial outsourced execution. - **GXP Bridge:** Deep expertise in either GMP or GCP with genuine working competence in the other. - **Systems Builder:** Hands-on experience configuring or materially building a QMS such as ZenQMS, Veeva Vault QMS, Qualio, MasterControl, or TrackWise. - **Data Integrity Command:** Strong grounding in data integrity and computer system validation fundamentals, including ALCOA+, 21 CFR Part 11, GAMP 5 categorization, and audit trail review. - **Inspection Experience:** You have participated in sponsor-side FDA GMP or BIMO inspection. **AI & Data Fluency** - **Emerging Regulatory Awareness:** You follow how regulators are approaching AI/ML in regulated environments and can reason about where the expectations are heading. - **Applied Context:** You are familiar how AI/ML can be applied to informed discovery, biomarker selection, dose selection, or trial design. - **Translation Over Expertise:** You can be the quality voice in a room of ML engineers/data scientists without needing to be an ML expert yourself. **Core Competencies** - **Risk-Based and Pragmatic:** You build fit-for-stage processes with the judgment to know when something is over-engineered. - **Hands-On Operator:** You are energized by rolling up your sleeves, writing the SOP, conducting the audit, and standing up the system. - **Cross-Functionally Credible:** You communicate quality and data integrity posture clearly to audiences who are not quality people. ## **Compensation & Benefits at insitro** Our target starting salary for successful US-based applicants for this role is $273,000 - $290,000. 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 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 @*[**](http://insitro.com)*, and if in doubt, contact us at* [*info@insitro.com*](mailto: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 [](http://www.insitro.com).