Insitro

Insitro

Director, Quality Assurance

South San Francisco, CA · Director

Sponsorship not specified$205k-$218kDetected 74 days ago
AlgorithmsGCPMachine LearningData EngineeringData ScienceGMPFDA RegulatoryResearchLeadershipCommunicationGxP

About the role

  • At our company, quality isn't a hurdle to innovation-it's the foundation that makes our data-driven insights trustworthy.
  • You will not just be checking boxes; you will be defining the regulatory standards for the future of AI-driven drug discovery.
  • As we transition into clinical-stage operations, we are looking for a Director of Quality Assurance to serve as a key architect of our quality culture.

Responsibilities

  • Build the Foundation: Design and implement a robust, phase-appropriate Quality Management System (QMS), including Document Control, Deviations, CAPAs, and Change Control
  • SOPs & Training: Author core SOPs and develop a streamlined training program that ensures compliance without creating unnecessary friction for the research and operations teams
  • Phase-Appropriate Strategy: Provide expert guidance on maintaining compliance for early-phase clinical work while building a scalable bridge toward future commercialization
  • Vendor Oversight: Lead the quality lifecycle for CROs/CMO/CDMOs. Perform audits for partners performing GLP, GCP, and GMP work to ensure they meet our internal and regulatory standards
  • Algorithmic Integrity: Partner with the Compute and Data Science teams to establish a framework for the validation of AI/ML models used in patient selection, biomarker discovery, or clinical endpoint analysis
  • Data Lineage & Governance: Collaborate with data engineers to ensure end-to-end traceability and data integrity-from raw biological data to final clinical insights
  • Continuous Validation: Develop "phase-appropriate" monitoring for evolving algorithms to manage and document model drift in a regulatory-friendly manner
  • Tech-Stack Qualification: Support the qualification of cloud-based compute environments to ensure they meet data storage and processing requirements for managing clinical data
  • Support to attend professional conferences that are meaningful to your career growth and role's responsibilities

Requirements

  • Proven Tenure: 10+ years of QA experience in biotech/pharma, with a track record of moving a small company through clinical entry
  • GXP Mastery: Expert knowledge of GLP, GCP, and GMP regulations

Compensation

  • Our target starting salary for successful US-based applicants for this role is $205,000 - $218,000.
  • 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.
  • We may also adjust this range in the future based on market data.
  • 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.
  • In addition, insitro also provides our employees:
  • 401(k) plan with employer matching for contributions

Benefits

  • 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.
  • You are not afraid to "roll up your sleeves" to write an SOP or file a report, while still maintaining the strategic vision of a department head
  • 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

Company info

  • Establish quality systems for research operations and business risk to protect the company's intellectual and physical assets
  • Serve as a primary advisor to leadership, providing clear direction to ensure the company remains compliant with FDA, EMA, and global regulations
  • 10+ years of QA experience in biotech/pharma, with a track record of moving a small company through clinical entry
  • You understand that "one size does not fit all" and can tailor quality solutions to the company's specific size and stage of development

Equal opportunity

  • insitro is an equal opportunity employer.
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