Sr.SoftwareQuality&ComplianceEngineer

Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® is designed to adapt to the complex and evolving understanding of cancer, providing its biopharmaceutical customers and clinicians with information on all of the approximately 20,000 human genes, together with the immune system, from a single tissue sample. In population sequencing, Personalis operates one of the largest sequencing operations globally and is currently the sole sequencing provider to Veterans Affairs' Million Veteran Program. To enable cancer and population sequencing, Personalis' Clinical Laboratory was built with a focus on clinical accuracy, quality, big data, scale and efficiency. The laboratory is GxP-aligned as well as Clinical Laboratory Improvement Amendments of 1988-certified and College of American Pathologists-accredited. Personalis is based in Fremont, California. Summary: We are seeking a proactive, self-motivated and detail-oriented Senior Software Quality & Compliance Engineer to serve as the vital bridge between innovative software development and rigorous regulatory and compliance standards.. In this high-impact role, you will spearhead Computer System Validation (CSV) initiatives, champion our Electronic Quality Management System (eQMS), and pioneer the integration of Artificial Intelligence (AI) into our quality frameworks. The ideal candidate will ensure that Personalis software products and internal systems are high-performing, compliant with global standards (including FDA 21 CFR Part 11 and 820, ISO 13485, and IEC 62304 etc), and primed for the next generation of automated quality oversight. Onsite: Monday, Tuesday, and Thursday Responsibilities: Computer System Validation (CSV): Drive the end-to-end GAMP 5 validation lifecycle for both internal software and cloud-based platforms. Take full ownership of authoring, executing, and finalizing critical compliance deli