Director of Quality for Regulated AI Life Sciences

Hippocratic AI; Menlo Park (CA); On-site; USD 180,000 - 280,000; Full time

Job summary

Hippocratic AI seeks a Director of Quality to establish and lead the QMS for its Life Sciences business in Menlo Park. You will embed quality across AI-enabled products used in clinical trials, patient engagement, and regulatory workflows.

You will build scalable quality processes, own CAPA, deviation, change control, and supplier quality, and partner with Product, Engineering, Regulatory, and Commercial teams to ensure ongoing compliance and readiness.

Qualifications

• Bachelor's degree in Life Sciences, Quality, Engineering, or regulatory field.
• 10+ years of quality/compliance experience in regulated life sciences environments.
• 5+ years of leadership building/managing quality systems and teams.
• Deep knowledge of ICH E6 (GCP), FDA/EU regulations, GxP, risk management, and vendor qualification/audit management.
• Experience establishing or enhancing a QMS from the ground up.
• Experience supporting customer audits and regulatory inspections.

Responsibilities

• Build and run the Quality Management System for Life Sciences products and services.
• Regulatory and audit readiness: ensure compliance with ICH E6, FDA/EU regs, and GxP; lead inspections.
• Extend Quality to AI products, vendors, and organizational processes; enable quality-by-design across lifecycle.

Skills

Quality system leadership

Regulatory compliance

GxP & ICH E6 knowledge

CAPA & change control

Vendor qualification & audits

AI/ML in regulated environments

Education

Bachelor's degree in Life Sciences or related

Advanced degree (MS/PhD/PharmD/MPH)

Regulatory affairs certification (RAC)

Tools

CSV familiarity

Job description

Hippocratic AI seeks a Director of Quality to establish and lead the QMS for its Life Sciences business in Menlo Park. You will embed quality across AI-enabled products used in clinical trials, patient engagement, and regulatory workflows.

You will build scalable quality processes, own CAPA, deviation, change control, and supplier quality, and partner with Product, Engineering, Regulatory, and Commercial teams to ensure ongoing compliance and readiness.