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insitro
South San Francisco, CA
Source: insitro careers · View original posting
From insitro's posting. “We” and “our” refer to the employer.
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.
Experience & Qualifications
12+ years in pharma or biotech quality, with progression into senior QA leadership.
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.
Deep expertise in either GMP or GCP with genuine working competence in the other.
Hands-on experience configuring or materially building a QMS such as ZenQMS, Veeva Vault QMS, Qualio, MasterControl, or TrackWise.
Strong grounding in data integrity and computer system validation fundamentals, including ALCOA+, 21 CFR Part 11, GAMP 5 categorization, and audit trail review.
You have participated in sponsor-side FDA GMP or BIMO inspection.
AI & Data Fluency
You follow how regulators are approaching AI/ML in regulated environments and can reason about where the expectations are heading.
You are familiar how AI/ML can be applied to informed discovery, biomarker selection, dose selection, or trial design.
You can be the quality voice in a room of ML engineers/data scientists without needing to be an ML expert yourself.
Core Competencies
You build fit-for-stage processes with the judgment to know when something is over-engineered.
You are energized by rolling up your sleeves, writing the SOP, conducting the audit, and standing up the system.
You communicate quality and data integrity posture clearly to audiences who are not quality people.
Compensation
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.
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.
Please be aware of recruitment scams: we never request payments, all recruitment communications are from @ insitro.com
, and if in doubt, contact us at info@insitro.com.
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.
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