Director of Quality for AI-Enabled Life Sciences

Hippocratic AI; Menlo Park (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

Hippocratic AI is seeking a Director of Quality in Menlo Park to establish and lead the Life Sciences QMS for AI-enabled solutions used in clinical trials, patient engagement, pharmacovigilance, and related use cases.

You will embed quality and compliance across the product lifecycle and service delivery, partnering with Product, Engineering, Regulatory, and Clinical teams to build a scalable framework that supports regulated AI products and audits.

Qualifications

• Bachelor's degree in Life Sciences, Quality, Engineering, Pharmacy, Regulatory Affairs, or related.
• 10+ years of progressive quality and compliance experience in regulated life sciences.
• 5+ years of leadership building quality systems and teams.
• Deep knowledge of ICH E6 (GCP), FDA and EU clinical trial regulations, GxP, risk management, and vendor qualification/audit management.
• Experience establishing or significantly enhancing a QMS from the ground up.
• Experience supporting customer audits and regulatory inspections.
• Strong understanding of software-enabled or digital health solutions operating in regulated environments.

Responsibilities

• Establish, implement, and continuously improve a scalable QMS for the Life Sciences business, including policies, procedures, and governance aligned with GxP requirements.
• Own CAPA, deviation, change control, document control, training, risk management, and supplier quality processes end to end.
• Build quality metrics, dashboards, and KPIs for executive leadership.
• Lead root cause investigations and management review, turning findings into continuous improvement initiatives.
• Operationalize applicable regulatory requirements and guidance into working quality processes (ICH E6, FDA CFR, EU CTR).
• Track evolving global regulation on AI, digital health, and life sciences tech, updating the QMS accordingly.
• Serve as quality SME in audits and inspections to keep the organization inspection-ready.
• Partner with Product and Engineering to embed quality-by-design into AI lifecycle, including validation and change governance.
• Establish qualification, monitoring, and audit programs for vendors, CROs, and subcontractors.
• Advise leadership on quality risk and build a scalable quality organization as the business scales.

Skills

Leadership

Quality management

Regulatory compliance

GxP knowledge

Vendor qualification

Cross-functional collaboration

Problem solving

Education

Bachelor's degree in Life Sciences/Quality/Engineering/Regulatory Affairs

Job description

Hippocratic AI is seeking a Director of Quality in Menlo Park to establish and lead the Life Sciences QMS for AI-enabled solutions used in clinical trials, patient engagement, pharmacovigilance, and related use cases.

You will embed quality and compliance across the product lifecycle and service delivery, partnering with Product, Engineering, Regulatory, and Clinical teams to build a scalable framework that supports regulated AI products and audits.