Hippocratic AI builds the safest generative AI healthcare agent for health systems, payors, and pharma. Over 180 million clinical interactions across 1,000+ use cases with 60+ partners worldwide. Backed by General Catalyst, Kleiner Perkins and a16z.
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
What they're looking for
- 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
More about this 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...
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