Director of Quality

About the Role

This role exists because quality-by-design doesn't have a playbook yet for AI-enabled products in regulated life sciences environments — you'll be the one writing it. As Director of Quality, you'll establish, lead, and continuously improve the Quality Management System (QMS) for Hippocratic AI's Life Sciences business, building a risk-based quality framework for AI-enabled solutions used in clinical trial operations, patient engagement, medical affairs, pharmacovigilance, and related use cases.

You'll partner closely with Product, Engineering, Clinical, Regulatory, Compliance, Security, Medical Affairs, and Commercial teams to embed quality and compliance throughout the product lifecycle and service delivery model.

What You'll Do

Build and run the quality system

• 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 that give executive leadership a real-time read on compliance and operational effectiveness.

• Lead root cause investigations and management review, turning findings into continuous improvement initiatives rather than one-off fixes.

Ensure regulatory and audit readiness

• Operationalize applicable regulatory requirements and guidance — ICH E6 (GCP), FDA clinical trial regulations (21 CFR 11, 50, 54, 56, 312), EU CTR 536/2014, GxP principles, and computerized system/software validation requirements — into working quality processes.

• Track evolving global regulation on AI, digital health, and life sciences technology, and translate it into changes to the QMS before it becomes a problem.

• Serve as the quality subject matter expert in customer audits, regulatory inspections, and due diligence — and keep the organization in a continuous state of inspection readiness.

Extend quality to AI products, vendors, and the org

• Partner with Product and Engineering to build quality-by-design into the AI development lifecycle, including validation and qualification strategies for software, AI models, and regulated workflows, and controls for model updates, release management, and change governance.

• Establish qualification, monitoring, and audit programs for vendors, CROs, technology partners, and subcontractors.

• Advise executive leadership on quality risk and compliance obligations, and build and mentor a quality organization as the business scales.

Location and Travel

We believe the best ideas happen together. To support fast collaboration and a strong team culture, this role is expected to be in our Menlo Park office five days a week.

What You Bring

Must-Have

• Bachelor's degree in Life Sciences, Quality, Engineering, Pharmacy, Regulatory Affairs, or a related discipline.

• 10+ years of progressive quality and compliance experience in pharmaceutical, biotechnology, medical device, CRO, clinical research, healthcare technology, or a related regulated industry.

• 5+ years of leadership experience building and managing quality systems and teams.

• Deep working knowledge of ICH E6 (GCP), FDA and EU clinical trial regulations, GxP quality systems, risk management methodologies, and vendor qualification/audit management.

• Demonstrated experience establishing or significantly enhancing a quality management system from the ground up.

• Experience supporting customer audits and regulatory inspections directly.

• Strong understanding of software-enabled or digital health solutions operating in regulated environments.

Nice-to-Have

• Advanced degree (MS, PharmD, PhD, MPH, or equivalent).

• ASQ Certified Quality Auditor (CQA), Certified Manager of Quality/Organizational Excellence (CMQ/OE), RAC, or a comparable certification.

• Experience with AI/ML-enabled products or SaaS platforms.

• Experience supporting clinical trials, patient support programs, pharmacovigilance operations, or medical information services.

• Familiarity with GAMP 5, computerized system validation (CSV), and software quality assurance methodologies.

• Experience scaling quality systems inside a high-growth technology company.

What Success Looks Like

• A comprehensive Life Sciences Quality Management System is established and operating.

• Core quality processes — CAPA, change control, supplier quality, audits, and management review — are implemented and functioning.

• Multiple pharmaceutical customers have completed audits with successful outcomes.

• A scalable framework supporting regulated AI products and services is in place.

• Executive leadership has measurable quality metrics and compliance dashboards to work from.

• Hippocratic AI is positioned as a trusted, inspection-ready partner for global life sciences organizations.