Insitro

2 months ago

Director, Quality Assurance

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 13 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

Glassdoor: 2.7

Website LinkedIn Glassdoor

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Insitro

2 months ago

Director, Quality Assurance

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 13 hours agoStatus: Live

Job Summary

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

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Scaleup

Funding: Series C

Headquarters: South San Francisco, United States

Founded: 2018

Glassdoor: 2.7

Website LinkedIn Glassdoor