Director, Quality Assurance

Insitro
United States
Workplace: HybridFull timeFunction: QA, Test & Release EngineeringExperience: 10+ yearsSkills: ["Communication","Leadership","Problem-solving"]

Lead the establishment of a robust quality management system and regulatory quality culture for AI-driven drug discovery. Balance GXP compliance with agile, data-driven operations, stand up clinical quality systems, manage global vendors, and partner with Compute/Data Science to validate AI-driven medicine while ensuring FDA/EMA regulatory alignment.

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Insitro
Insitro
3 months ago

Director, Quality Assurance

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Source: Company careers pageValidated by: Fursa AI
Last checked: 21 hours agoStatus: Live

Job Summary

Lead the establishment of a robust quality management system and regulatory quality culture for AI-driven drug discovery. Balance GXP compliance with agile, data-driven operations, stand up clinical quality systems, manage global vendors, and partner with Compute/Data Science to validate AI-driven medicine while ensuring FDA/EMA regulatory alignment.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: QA, Test & Release Engineering

Key Responsibilities

  • •Build and lead a phase-appropriate Quality Management System (QMS) including Document Control, Deviations, CAPAs, and Change Control.
  • •Author core SOPs and develop a streamlined training program to ensure compliance without friction for research and operations teams.
  • •Provide expert guidance on maintaining compliance for early-phase clinical work while building a scalable bridge toward future commercialization.
  • •Lead the quality lifecycle for CROs/CMO/CDMOs, performing audits for partners performing GLP, GCP, and GMP work to ensure regulatory standards.
  • •Partner with Compute/Data Science teams to establish a framework for validating AI/ML models used in clinical endpoints and ensure end-to-end data lineage and governance.

Pay and Benefits

Perks:401kMedicalDentalVisionParental LeaveHome OfficeCommuter Benefits

Key Requirements

  • •10+ years of QA experience in biotech/pharma with a track record of moving a small company through clinical entry
  • •Expert knowledge of GXP regulations (GLP, GCP, GMP)
  • •Extensive experience conducting vendor audits and preparing for regulatory inspections
  • •Working understanding of Computer System Validation and dialogue with software/IT engineers about data pipelines and controls
  • •Hands-on builder who can write SOPs or reports while maintaining strategic department leadership
Experience:10+ yearsBiotechBiopharmaAIDrug discoveryClinical
Skills:CommunicationLeadershipProblem-solving
Languages:English
Tech Stack:Cloud computingData governanceQuality Management SystemSOPCAPA

Company Brief

Insitro
Insitro is a machine-learning-driven drug discovery and development company that integrates high-throughput biology, human genetics, and AI to identify therapeutic targets and design medicines across metabolic and neurodegenerative diseases.
Industry: Biotech
Company Size: Large (251 to 1,000 employees)
Growth: Scaleup
Funding: Series C
Headquarters: South San Francisco, United States
Founded: 2018
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