Director of Quality (AI)

Location: Menlo Park, California, United States; on-site five days a week

Company

Hippocratic AI is building a safety-focused, healthcare-only large language model and AI platform for improving patient outcomes.

What you will do

• Establish, operate, and continuously improve a scalable Life Sciences Quality Management System aligned with GxP requirements.
• Own CAPA, deviation, change control, document control, training, risk management, supplier quality, and management review processes.
• Translate ICH E6, FDA clinical trial regulations, EU CTR, GxP, and software validation requirements into operational quality processes.
• Lead customer audits, regulatory inspections, due diligence, root cause investigations, and continuous improvement initiatives.
• Partner with Product and Engineering on quality-by-design, AI model validation, regulated workflow controls, release management, and change governance.
• Build vendor qualification and audit programs and mentor a growing quality organization.

Requirements

• Bachelor's degree in Life Sciences, Quality, Engineering, Pharmacy, Regulatory Affairs, or a related discipline.
• 10+ years of progressive quality and compliance experience in a regulated industry.
• 5+ years of leadership experience building and managing quality systems and teams.
• Deep knowledge of ICH E6 (GCP), FDA and EU clinical trial regulations, GxP quality systems, risk management, and vendor qualification.
• Experience establishing or significantly enhancing a QMS, supporting customer audits and regulatory inspections, and working with software-enabled or digital health solutions.
• Ability to work on-site in the Menlo Park office five days per week.

Nice to have

• Advanced degree such as MS, PharmD, PhD, MPH, or equivalent.
• ASQ CQA, CMQ/OE, RAC, or comparable certification.
• Experience with AI/ML products, SaaS platforms, clinical trials, patient support, pharmacovigilance, or medical information services.
• Familiarity with GAMP 5, computerized system validation, and software quality assurance.
• Experience scaling quality systems in a high-growth technology company.

Culture & Benefits

• Work alongside physicians, hospital leaders, AI researchers, and technology experts focused on safety-first healthcare AI.
• Collaborate closely across Product, Engineering, Clinical, Regulatory, Compliance, Security, Medical Affairs, and Commercial functions.
• Join a high-growth company backed by leading healthcare and AI investors.
• Equal opportunity workplace with accommodations available during the hiring process.