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Director of Quality

Hippocratic AI· G&A
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Menlo Park, CAFull-timePosted 4w ago

About the role

Director of Quality - Life Sciences responsible for building and deploying the Life Sciences Quality program, managing the quality management system, and ensuring all policies, SOPs, records, and validation packages meet applicable requirements. Partners with Product, Engineering, Clinical, Regulatory, Security, Medical Affairs, and Commercial teams to keep quality evidence current, train staff, and ensure audits meet pharma/biotech/medtech standards.

Responsibilities

  • Build and maintain the quality system: Establish and run a GxP-aligned quality management system for Life Sciences, covering document control, CAPA, deviations, change control, and training records.
  • Own computerized system validation for the software and AI-enabled workflows the business runs on, including validation plans, test protocols, and traceability matrices.
  • Maintain a single source of truth for every quality record, SOP, and validation artifact for audit readiness.
  • Run periodic internal audits and management review to identify and remediate gaps.
  • Lead the company through customer quality audits and regulatory inspections end to end, from pre-audit preparation through closing CAPAs.
  • Partner with Engineering to embed validation and change control into the software development lifecycle for audit-ready releases.
  • Establish a vendor and subcontractor qualification program aligned with Life Sciences customer expectations.
  • Track evolving Life Sciences quality expectations for AI-enabled tools and adjust processes ahead of audits.
  • Design and run mock audits and inspection simulations to test quality program readiness.

Qualifications

  • Bachelor's degree in Life Sciences, Quality, Engineering, or a related field.
  • 8+ years of quality experience in pharmaceutical, biotechnology, CRO, or healthcare technology with direct ownership of GxP systems.
  • 3+ years leading teams or programs responsible for audit and inspection readiness.
  • Hands-on experience with computerized system validation (CSV) and GxP documentation practices for software or digital tools.
  • Track record of preparing internal teams for and passing customer audits or regulatory inspections.
  • Working knowledge of CAPA, deviation management, change control, and document control in a regulated environment.
  • Comfort working directly with Life Sciences customer quality and compliance teams during vendor audits.

Skills

Required:GxP quality managementComputerized System Validation (CSV)Audit readiness and regulatory inspections
Last updated Sep 23, 2026. Interested? Apply on the company site.

About Hippocratic AI

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