Teams at Personalis

Lead design, development, testing, deployment, and maintenance of regulated clinical-lab software. Provide technical leadership, mentor engineers, improve CI/CD and integrations, ensure compliance (HIPAA, CLIA, CAP, FDA), support validation, and collaborate with stakeholders to deliver secure, reliable applications.

Lead computer system validation (GAMP 5) and software quality/compliance for clinical genomics software. Author/execute validation deliverables, enforce FDA/ISO/IEC regulatory alignment, run risk assessments (FMEA), integrate AI governance into QMS, support eQMS configuration, collaborate on cybersecurity and cross-functional design control documentation, and serve as SME during audits.

Lead the global internal audit program and external audit readiness for a GxP-aligned clinical laboratory. Oversee audit lifecycle, regulatory inspections, executive reporting, CAPA investigations, and continuous improvement. Partner with cross-functional leaders, mentor audit staff, and ensure compliance with CLIA, CAP, ISO 13485, 21 CFR 820, IVDR, GCP, and GCLP.