At insitro, we are building a different kind of drug company to bring better drugs faster to the patients who can benefit most. Through the power of machine learning (ML) and data at scale, we decode the complexities of biology to unlock transformative new... Backed by SoftBank VF, a16z and GV.
About the role
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.
What they're looking for
- 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
More about this role
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...
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