About the job
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. This is a 'player-coach' role designed for a leader who can balance rigorous GXP compliance with the agility required in a data-driven, AI-forward company. You will stand up our clinical quality systems, manage global vendors, and partner with our Compute organization to define how the next generation of AI-driven medicine is validated and regulated.
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
Qualifications
Minimum
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
Audit Experience: Extensive experience conducting vendor audits and preparing for regulatory inspections
Tech Literacy: Working understanding of Computer System Validation and a comfort level discussing data pipelines and controls with software and IT engineers
Preferred
No preferred qualifications listed.