Director of Quality AI-Enabled Life Sciences

About the Role

As Director of Quality - Life Sciences, you'll build and deploy the systems, documentation, and internal practices that enhance the Life Sciences Quality program. You'll be responsible for the quality management system for our Life Sciences business and make sure every policy/sop process, record, and validation package meets all applicable requirements

You'll work closely with Product, Engineering, Clinical, Regulatory, Security, Medical Affairs, and Commercial teams to keep quality evidence current, train and educate Hippocratic AI colleagues, and ensure the Life Sciences Quality program meets the standards and requirements of our pharma, biotech and medtech clients.

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 that hold up under review.

• Maintain a single source of truth for every quality record, SOP, and validation artifact so it can be produced on short notice during an audit.

• Run periodic internal audits and management review to identify and remediate gaps.

Establish audit readiness across the business

• Lead the company through customer quality audits and regulatory inspections end to end, from pre-audit preparation through closing CAPAs.

• Partner with Engineering to build validation and change control practices directly into the software development lifecycle, so every release ships audit-ready.

• Establish a vendor and subcontractor qualification program that mirrors what Life Sciences customers expect from their suppliers.

• Track how Life Sciences quality expectations for AI-enabled tools are evolving, adjust processes ahead of the next audit cycle.

• Design and run mock audits and inspection simulations that evaluate the robustness and readiness of the quality program.

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.

• 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 successfully 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.

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

• ASQ Certified Quality Auditor (CQA) or Certified Manager of Quality/Organizational Excellence (CMQ/OE).

• Experience validating AI/ML-enabled or SaaS platforms under GxP (Pharma).

• Background running mock audits, inspection simulations, or auditor coaching programs.

• Familiarity with GAMP 5 and risk-based validation approaches.

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

• The Life Sciences quality management system runs cleanly, with current documentation and no open gaps.

• Multiple life sciences customers have completed vendor audits with successful outcomes.

• Computerized system validation packages are complete and defensible for every…