Senior Director, Quality Assurance
About The Position
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.
Requirements
- 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.
- 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.
- 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.
Responsibilities
- 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
- 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
- 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
- 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
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
