Director, Quality Assurance

About the role

You will define the regulatory standards that make AI-driven drug discovery trustworthy rather than treating quality as a barrier to innovation. This role is a strategic "player-coach" position that balances rigorous GXP compliance with the agility required in a data-driven environment. You will establish clinical quality systems from the ground up while managing a portfolio of global vendors to ensure adherence to strict standards. The position involves close collaboration with the Compute organization to align algorithmic validation with regulatory expectations. You will partner across functions to embed quality into the daily workflow without creating unnecessary friction. This role reports directly to the Chief Technology Operations Officer and operates in a hybrid schedule of either three days per week or one full week per month in South San Francisco.

Key facts

What you'll do

• Architect and implement a phase-appropriate Quality Management System (QMS) that covers Document Control, Deviations, CAPAs, and Change Control.
• Author core Standard Operating Procedures and design a streamlined training program that ensures compliance while enabling research and operations agility.
• Provide expert guidance on maintaining compliance during early-phase clinical work and building a scalable bridge toward commercialization.
• Lead the quality lifecycle for Contract Research Organizations, Contract Manufacturers, and Contract Development and Manufacturing Organizations, performing audits for partners engaged in GLP, GCP, and GMP activities.
• Partner with Compute and Data Science teams to establish a framework for the validation of AI and Machine Learning models used in patient selection, biomarker discovery, and clinical endpoint analysis.
• Collaborate with data engineers to ensure end-to-end data lineage and integrity, tracing data from raw biological inputs to final clinical insights.
• Develop continuous validation approaches for evolving algorithms to monitor and document model drift in a regulatory-friendly manner.
• Support the qualification of cloud-based compute environments to confirm they meet data storage and processing requirements for managing clinical data securely.
• Establish quality systems for research operations and business risk management to protect the company's intellectual and physical assets.
• Partner with diverse teams, including bench scientists and machine learning engineers, to demystify compliance and integrate quality into everyday workflows.
• Serve as a primary advisor to leadership, providing clear direction to ensure compliance with FDA, EMA, and global regulations.
• Drive the development of phase-appropriate monitoring strategies for AI/ML systems to ensure ongoing compliance and model performance.
• Define and own the documentation control process to ensure that all quality records and procedural documents are current, accessible, and audit-ready.
• Act as a liaison with regulatory and inspection teams, preparing the organization for audits and inspections through robust internal oversight.

Requirements

• Bring 10+ years of Quality Assurance experience in the biotechnology or pharmaceutical industry with a proven track record of moving a small company through clinical entry.
• Demonstrate expert knowledge of Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP) regulations.
• Possess extensive experience conducting vendor audits and preparing for regulatory inspections across CROs, CMOs, and CDMOs.
• Hold a working understanding of Computer System Validation and feel comfortable discussing data pipelines and controls with software and IT engineers.
• Show hands-on capability to "roll up your sleeves" by writing Standard Operating Procedures and filing reports while maintaining strategic oversight of the quality department.
• Thrive in environments with ambiguity, creating quality processes and systems where none previously existed.
• Apply a pragmatic mindset to tailor quality solutions that fit the specific size and stage of development of the company.
• Exhibit collaborative influence by providing firm compliance guidance while remaining a supportive partner to technical and scientific stakeholders.

Nice to have

No items in the Nice to have section were provided in the SOURCE document.

Practical notes

This role is based in South San Francisco, California, and operates under full-time engagement. The position follows a hybrid schedule requiring either three days per week or one full week per month of in-person presence. Compensation details are outlined separately, with a target starting salary range of $205,000 to $218,000, subject to adjustment based on skills, experience, market demand, business needs, and internal equity considerations. Eligibility for an Annual Performance Bonus Plan and an Equity Incentive Plan is available, subject to plan terms and company performance. No specific travel requirements, visa sponsorship details, or application deadlines were provided in the SOURCE material.