← All roles

Senior Director, Quality Assurance

insitro· Technical Operations
Apply on company site
South San Francisco, CA$205k - $218kFull-timePosted 4mo ago

About the role

Senior leader responsible for building and operating insitro's quality function for clinical-stage operations, covering GMP/GCP quality, clinical data quality, data integrity, and QMS development in a largely outsourced development environment.

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

Qualifications

  • 12+ years in pharma or biotech quality, with progression into senior QA leadership
  • Advanced molecule from preclinical through IND and into Phase 2 or beyond in outsourced setting
  • Deep expertise in GMP or GCP with working competence in the other
  • Hands-on experience configuring or building a QMS (e.g., ZenQMS, Veeva Vault QMS, Qualio, MasterControl, TrackWise)
  • Strong data integrity and computer system validation fundamentals (ALCOA+, 21 CFR Part 11, GAMP 5, audit trails)
  • Experience in sponsor-side FDA GMP or BIMO inspections
  • Emerging regulatory awareness for AI/ML in regulated environments
  • Ability to translate ML/AI concepts for quality discussions without being ML expert
  • Risk-based, pragmatic mindset; hands-on with SOPs, audits, and system implementation
  • Cross-functional credibility and ability to communicate quality posture to non-quality audiences

Skills

Required:Quality Management System (QMS) implementationGMP/GCP expertiseData Integrity & CSV/IVTAudit & Inspection ReadinessCross-functional leadership
Nice to have:AI/ML regulatory awareness

Benefits

  • 401(k) plan with employer matching
  • Excellent medical, dental, and vision coverage with mental health support
  • Open, flexible vacation policy
  • Paid parental leave (16 weeks for birth, 10 weeks for new parent)
  • Quarterly budget for books and online courses
  • Support to attend professional conferences
  • New hire stipend for home office setup
  • Monthly cell phone & internet stipend
  • Free onsite baristas and daily lunch for onsite/hybrid employees
  • Free commuter bus network to South San Francisco HQ
Last updated Sep 3, 2026. Interested? Apply on the company site.

About insitro

Making Medicines Differently

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 medicines.

PipelinePlatformPeoplePublications & PressML-driven platformdrug discoveryneurosciencemetabolism
Company profileWebsite

More open roles at insitro