Personalis, Inc

Personalis, Inc

Sr. Software Quality & Compliance Engineer

Fremont, CA · Senior · Full-time

Sponsorship not specified$130k-$155kDetected 41 days ago
Machine LearningComplianceClinical Laboratory TechniquesFDA RegulatoryBioinformaticsMedical DevicesLeadershipCommunicationPublic SpeakingGxP

About the role

  • Personalis, Inc. is a leader in advanced cancer genomics for enabling the next generation of precision cancer therapies and diagnostics.
  • 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.

Responsibilities

  • Computer System Validation (CSV): Drive the end-to-end GAMP 5 validation lifecycle for both internal software and cloud-based platforms.
  • Cybersecurity - Champion a secure-by-design culture by collaborating seamlessly with IT, ensuring our digital infrastructure and software products maintain a proactive, audit-ready posture against emerging cybersecurity threats.
  • Audit Support: Serve as the primary SW Quality Subject Matter Expert (SME) during internal and external audits, confidently presenting and defending validation packages and quality processes to regulatory bodies.
  • eQMS Support: As the SW Quality Subject Matter Expert, driving continuous improvement in system configuration and user workflows champion uncompromising data integrity across foundational quality modules in the eQMS such as Document Control, CAPA, and Change Management.
  • Drive rigorous cross-functional alignment by partnering closely with Software Development and SQA teams: Provide expert guidance on accurate generation of essential design control documentation, including Software/System Requirement Specifications, Architecture, Testing protocols/reports, and System Risk Analyses.
  • Drive rigorous cross-functional alignment by partnering closely with
  • Provide expert guidance on accurate generation of essential design control documentation, including Software/System Requirement Specifications, Architecture, Testing protocols/reports, and System Risk Analyses.
  • AI Integration & Governance: Partner with Quality leadership to integrate AI-driven tools into the QMS.

Requirements

  • CSV Expertise: Proven track record of validating complex software systems and maintaining a "validated state" through rigorous change control.
  • eQMS Proficiency: Deep hands-on experience managing or implementing platforms such as MasterControl, Veeva, Arena, or ETQ Reliance.
  • AI Exposure: Demonstrate a strong working knowledge of AI/ML principles, combined with a clear strategic focus on governing and applying these technologies compliantly within a mature Quality Management System.
  • Exhibit exceptional communication skills, with a proven track record of translating complex regulatory software requirements into clear, actionable guidance for cross-functional teams.

Nice to have

  • 5-8 years of direct experience in Software Quality Assurance or Compliance within a regulated industry (Diagnostics, MedTech, Pharma, or Biotech preferred).
  • Preferred Skills:

Skills

  • Hands-on experience within global frameworks-specifically the FDA, IVDR (EU 2017/746), or MDR (EU 2017/745)-is a strong plus.
  • The hiring range for this position is $130,000 to $155,000 per year, which may factor in various geographic regions.
  • Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals.
  • Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities.
  • #LI-KK1 #LI-Hybrid
  • Cybersecurity

Compensation

  • The hiring range for this position is $130,000 to $155,000 per year, which may factor in various geographic regions.

Benefits

  • Develop robust, risk-based frameworks for AI validation to ensure all machine learning models utilized in quality processes remain transparent, traceable, and fully compliant.

Company info

  • 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.
  • 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.
  • At Personalis, we value your security.
  • We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.

Equal opportunity

  • Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities.
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