Director of Quality

BackHippocractic AIDirector of QualityMenlo Park, CAAbout the roleAbout the RoleThis 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 DoBuild and run the quality systemEstablish, 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 readinessOperationalize 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 orgPartner 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 TravelWe 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 BringMust-HaveBachelor'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-HaveAdvanced 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 LikeA 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.Why Join Hippocratic AIReinvent healthcare with AI that puts safety first. We’re building the world’s first healthcare‑only, safety‑focused LLM — a breakthrough platform designed to transform patient outcomes at a global scale. This is category creation.Work with the people shaping the future. Hippocratic AI 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.Backed by the world’s leading healthcare and AI investors. We recently raised a $126M Series C at a $3.5B valuation, led by Avenir Growth, bringing total funding to $404M with participation from CapitalG, General Catalyst, a16z, Kleiner Perkins, Premji Invest, UHS, Cincinnati Children’s, WellSpan Health, John Doerr, Rick Klausner, and others.Build alongside the best in healthcare and AI. Join experts who’ve spent their careers improving care, advancing science, and building world‑changing technologies — ensuring our platform is powerful, trusted, and truly transformative.Equal OpportunityHippocratic AI is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic information, military or veteran status, or any other characteristic protected by applicable law. We are committed to building a team that reflects the patients we serve. We actively encourage applications from candidates of all backgrounds. If you require accommodations during the hiring process, please contact [email protected].Please be aware of recruitment scams impersonating Hippocratic AI. All recruiting communication will come from @hippocraticai.com email addresses. We will never request payment or sensitive personal information during the hiring process.About Hippocractic AIHippocratic AI presents a platform that develops safety-focused large language models tailored for healthcare settings. The company offers AI agents designed to engage in non-diagnostic, patient-facing tasks such as preoperative preparation, post-discharge follow-up, and chronic-care management. Its architecture is built on a multi-agent system that aims to reduce clinician burden by managing routine patient interactions, while a clinician-driven test framework ensures service readiness. The service includes an “agent store” where licensed clinicians can design and deploy new agents across diverse specialties, and health systems, payers, or providers can deploy them to support outreach and engagement workflows.Other roles at Hippocractic AIForward Deployment Engineer (Residency Program)Menlo Park, CAInterested?Let me introduce you to the founders.Skip the processJob detailsLocationMenlo Park, CACompanyNameHippocractic AIIndustryArtificial Intelligence (AI)Team Size3View profileFundingTotal raised$404MLast stageGrowthInvestorsAndreessen HorowitzGeneral CatalystKleiner PerkinsAAvenir GrowthNNVIDIA NVenturesFoundersMSMunjal ShahCo-Founder & CEOLinkedInVPVishal ParikhCo-Founder & Chief Product OfficerSMSubhabrata MukherjeeCo-Founder & Chief Science OfficerWhat happens next.No applications, no recruiter spam. Just the intro.01Confirm the fitA few questions to make sure this role is the right shape for you. Two minutes.02I pitch you to the companyI write the intro, send it to the founder, and handle the back-and-forth.03A meeting lands on your calendarIf they’re a yes, I book the chat. You show up — that’s the whole job-hunt.