Personalis, Inc

Personalis, Inc

Sr. Manager / Associate Director, Quality Audits

Fremont, CA · Director · Full-time

Sponsorship not specified$165k-$210kDetected 13 days ago
GCPProject ManagementExcelAuditingClinical Laboratory TechniquesFDA RegulatoryBioinformaticsMedical DevicesLeadershipCommunicationCollaborationMentoringMicrosoft OfficeInternal AuditGxP

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

  • Regulatory & Licensure Support: Lead external regulatory inspections and support the preparation and submission of crucial documentation for licensure and accreditation.
  • Stakeholder Engagement: Actively partner with department heads and process owners to communicate audit results, evaluate systemic findings, and collaboratively resolve complex, audit-related compliance issues.
  • Root Cause & Investigation Leadership: Provide expert guidance and lead cross-functional investigation teams in executing comprehensive root cause analyses for CAPAs, deviations, and non-conformances stemming from internal and external audits.
  • Continuous Improvement: Champion continuous improvement initiatives across all Quality Systems, leveraging audit insights to drive operational excellence and robust process controls.

Requirements

  • Deep, expert-level knowledge of ISO 13485, 21 CFR 820, ICH E6 (R3) Guidance for GCP, GCLP, CLIA, and CAP regulations.

Nice to have

  • Bachelor's degree in a scientific, engineering, or related discipline.
  • Advanced degree or professional audit certifications (e.g., ASQ CQA, Lead Auditor certification) highly preferred.

Skills

  • The hiring range for this position is $165,000 to $210,000 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

Compensation

  • The hiring range for this position is $165,000 to $210,000 per year, which may factor in various geographic regions.
  • Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Benefits

  • Establish, maintain, and oversee the strategic vision for the corporate Internal Audit program and external audit readiness frameworks to ensure compliance with CLIA, CAP, ISO 13485, 21 CFR 820, IVDR, and GCP and GCLP.
  • The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.
  • Education and Experience:
  • Education: Bachelor's degree in a scientific, engineering, or related discipline.

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.
  • As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations.
  • Protecting Our Candidates: 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.
  • At Personalis, we value your security.

Equal opportunity

  • equal opportunity employer and is committed to the full inclusion of all individuals.
  • Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities.
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