Sr. Software Quality & Compliance Engineer

Sr. Software Quality & Compliance Engineer Fremont, CA Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics. The Personalis NeXT Platform® enables comprehensive analysis from a single tissue sample and supports large-scale sequencing operations. The laboratory is GxP-aligned and CLIA-certified and CAP-accredited. Personalis is based in Fremont, California. Summary We are seeking a proactive, self-motivated and detail-oriented Senior Software Quality & Compliance Engineer to bridge software development with regulatory and compliance standards. In this role, you will lead Computer System Validation (CSV) initiatives, champion the Electronic Quality Management System (eQMS), and help integrate AI into quality frameworks. The candidate will ensure Personalis software products and internal systems are high-performing, compliant with global standards (including FDA 21 CFR Part 11 and 820, ISO 13485, IEC 62304, etc.), and prepared for advanced automated quality oversight. Onsite: Monday, Tuesday, and Thursday Responsibilities Computer System Validation (CSV): Drive the end-to-end GAMP 5 validation lifecycle for internal software and cloud-based platforms. Own authoring, execution, and finalization of critical compliance deliverables, including Validation Plans, IQ/OQ/PQ, and Validation Summary Reports. Regulatory Compliance: Ensure alignment with regulatory requirements across software development activities, including FDA 21 CFR 820, 21 CFR Part 11, EU Annex 11, and IEC 62304. Risk Management: Lead proactive risk assessments (FMEA) to identify software hazards early and implement mitigation across the CSV and SDLC. AI Integration & Governance: Collaborate with Quality leadership to integrate AI-driven tools into the QMS and develop risk-based AI validation frameworks to ensure models are transparent, traceable, and compliant. Cybersecurity: Promote a secure-by-design culture with IT to maintain an audit-ready posture against cybersecurity threats. Audit Support: Serve as the primary SW Quality Subject Matter Expert (SME) during internal and external audits, presenting and defending validation packages and quality processes to regulators. eQMS Support: Drive continuous improvement in eQMS configurations and user workflows to ensure data integrity in modules such as Document Control, CAPA, and Change Management. Cross-Functional Alignment: Partner with Software Development and SQA teams to guide design control documentation, including Software/System Requirements, Architecture, Testing protocols/reports, and System Risk Analyses. Required Qualifications Education: BS in computer science or related field or equivalent experience. Experience: 5–8 years in Software Quality Assurance or Compliance within regulated industries (Diagnostics, MedTech, Pharma, or Biotech preferred). CSV Expertise: Proven ability to validate complex software systems and maintain a validated state through change control. eQMS Proficiency: Hands-on experience with platforms such as MasterControl, Veeva, Arena, or ETQ Reliance. Technical Knowledge: Deep understanding of SDLC methodologies (Agile, V-Model) and experience resolving Non-Conformances (NC), CAPA, and Complaint handling. AI Exposure: Working knowledge of AI/ML principles with focus on governing AI within a mature Quality Management System. Preferred Skills Excellent communication skills with the ability to translate regulatory requirements for cross-functional teams. Experience with global regulatory frameworks (FDA, IVDR, MDR) is a strong plus. The hiring range for this position is $130,000 to $155,000 per year, with actual offers determined by geographic region, experience, and other factors. Full-time positions include an annual performance-based bonus and long-term incentive units, plus benefits such as medical, financial, and other offerings depending on level and role. Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. Reasonable accommodations are available for applicants with disabilities. If you need an accommodation to participate in the job application or interview process, please contact your recruiter. Protecting Our Candidates: All official correspondence from our team will come exclusively from personlis.com email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to prosecute cyber crimes targeting our community. #J-18808-Ljbffr Personalis, Inc