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Hippocratic AI is building a healthcare-only, safety-focused LLM platform to transform patient outcomes globally. As Director of Quality, you will establish, lead, and continuously improve the Quality Management System (QMS) for the 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 will 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.
Key responsibilities include:
**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 real-time visibility on compliance and operational effectiveness. Lead root cause investigations and management review, turning findings into continuous improvement initiatives.
**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. Serve as the quality subject matter expert in customer audits, regulatory inspections, and due diligence, keeping the organization in a continuous state of inspection readiness.
**Extend quality to AI products, vendors, and the organization:** 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.
Success looks like: a comprehensive Life Sciences QMS established and operating; core quality processes (CAPA, change control, supplier quality, audits, management review) implemented and functioning; multiple pharmaceutical customers completing audits with successful outcomes; a scalable framework supporting regulated AI products and services in place; executive leadership with measurable quality metrics and compliance dashboards; and Hippocratic AI positioned as a trusted, inspection-ready partner for global life sciences organizations.
The company was co-founded by CEO Munjal Shah and a team of physicians, hospital leaders, AI pioneers, and researchers from institutions like El Camino Health, Johns Hopkins, Washington University in St. Louis, Stanford, Google, Meta, Microsoft, and NVIDIA. Recently raised a $126M Series C at a $3.5B valuation, with total funding of $404M.
**Requirements:**
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 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
