Director of Quality, AI Life Sciences (QMS)

Hippocratic-Ai; Menlo Park (CA); On-site; USD 210,000 - 320,000; Full time

Job summary

Hippocratic AI in Menlo Park is seeking a Director of Quality to establish and continually improve the QMS for our Life Sciences business, aligning quality with AI-enabled solutions across regulated workflows.

You will partner with Product, Engineering, Regulatory, Compliance, Security, and Medical Affairs to embed quality throughout the product lifecycle and service delivery, scaling the quality organization as the business grows.

Qualifications

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

Responsibilities

• Build, implement, and continuously improve a scalable QMS for Life Sciences.
• Own CAPA, deviation, change control, document control, training, risk management, and supplier quality.
• Build quality metrics, dashboards, and KPIs for real-time leadership insight.
• Lead root cause investigations and management review for continuous improvement.

Skills

Quality leadership

QMS design & improvement

Regulatory knowledge

GxP & ICH E6

Audits & inspections

Vendor qualification/audit mgmt

Education

Bachelor's in Life Sciences or regulatory

Advanced degree (MS/PhD/MBA)

Job description

Hippocratic AI in Menlo Park is seeking a Director of Quality to establish and continually improve the QMS for our Life Sciences business, aligning quality with AI-enabled solutions across regulated workflows.

You will partner with Product, Engineering, Regulatory, Compliance, Security, and Medical Affairs to embed quality throughout the product lifecycle and service delivery, scaling the quality organization as the business grows.