Insitro

Insitro

Senior Director, Quality Assurance

South San Francisco, CA · Director

Sponsorship not specified$273k-$290kDetected 46 days ago
AlgorithmsGCPMachine LearningData ScienceGMPFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationGxP

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odds of building a lasting career here

57Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role76
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.

Lottery odds assume a STEM candidate.

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H-1B wage level

the lottery is wage-weighted — each level is one more entry

Level IV · 4×
Level I$80,5791 entry
Level II$108,4722 entries
Level III$136,3443 entries
Level IV$164,2374 entries

This range already reaches Level IV — the maximum four lottery entries.

DOL prevailing wage, 2026-27 wage year · Software Quality Assurance Analysts and Testers (15-1253) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.

Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.

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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.
  • 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.

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
  • 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
  • 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 to attend professional conferences that are meaningful to your career growth and role's responsibilities

Requirements

  • Experience & Qualifications
  • 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.
  • Deep expertise in either GMP or GCP with genuine working competence in the other.
  • You have participated in sponsor-side FDA GMP or BIMO inspection.
  • 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.
  • You are energized by rolling up your sleeves, writing the SOP, conducting the audit, and standing up the system.

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.
  • 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.

Benefits

  • 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)
  • New hire stipend for home office setup
  • Monthly cell phone & internet stipend
  • 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.
  • 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

Company info

  • 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.

Equal opportunity

  • insitro is an equal opportunity employer.

Visa & Work Authorization

  • Own Clinical Quality: Lead TMF quality, clinical audit planning, and sponsor oversight activities in partnership with clinical operations and data management
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This listing is sourced directly from Insitro's careers page and normalized into a canonical job model.