Sr. Manager / Associate Director, Quality Events

Personalis, Inc.; Fremont (CA); Hybrid; USD 160,000 - 220,000; Full time

Job summary

Personalis, Inc. in Fremont, California, seeks a Sr. Manager/ Associate Director for Nonconformance & CAPA Management to own NC, CAPA, PD, and Quality Investigation programs across the enterprise.

The role ensures strict compliance with FDA 21 CFR Part 820, ISO 13485:2016, CLIA/CAP, and global IVD requirements, driving proactive prevention through data-driven oversight. This position reports to the Sr. Director of Quality Assurance and collaborates with Clinical Laboratory Operations, Assay

Qualifications

• 8–10+ years in QA/Quality Systems in FDA-regulated IVD/medical device environments.
• At least 4+ years in formal program management or leadership roles.
• Strong knowledge of 21 CFR Part 820, ISO 13485:2016.
• Familiarity with CLIA, CAP, NYS CLEP, and EU IVDR is highly preferred.

Responsibilities

• Provide end-to-end governance for NC, CAPA, PD, and QC investigations.
• Chair CAPA & QRB; drive robust root-cause analyses and risk-based prioritization.
• Oversee investigation lifecycle with structured problem-solving methods (5-Why, Ishikawa, DMAIC).
• Establish Verification/Effectiveness Checks to prevent recurrence and protect device safety.
• Present governance dashboards and metrics to Management Review and Quality Exec Committee.

Skills

Quality Assurance

Quality Systems

Program management

Leadership

Regulatory knowledge

Risk management

Tools

eQMS

Job description

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California.

Summary

As an essential leader within the Quality Assurance & Regulatory Compliance organization, the Sr. Manager/ Associate Director of Nonconformance & CAPA Management provides enterprise-level ownership, strategic leadership, and program governance over the company’s Nonconformance (NC), Corrective and Preventive Action (CAPA), Planned Deviation (PD), and Quality Investigation systems.

This role serves as the authoritative subject matter expert (SME) ensuring strict compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485:2016, CLIA/CAP, and applicable global in vitro diagnostic (IVD) regulatory requirements. The incumbent is responsible for driving organizational maturity from reactive compliance to proactive, data-driven prevention, presenting critical health-of-quality metrics to executive leadership, and championing continuous process improvement across Clinical Laboratory Operations, Assay Development, and Manufacturing/Supply Chain. This position reports to the Sr. Director of Quality Assurance.

Hybrid

Hybrid: Monday and Tuesday onsite, plus additional days as needed.

Responsibilities

• Strategic Program Oversight & Governance
  • Provide end-to-end program oversight and governance for the global Nonconformance (NC), Planned Deviation (PD), and CAPA systems, ensuring standard operating procedures reflect best industry practices and regulatory expectations.
  • Chair and direct the cross-functional CAPA & Quality Review Board (QRB), ensuring robust root-cause analyses, risk-based prioritization, actionable containment, and timely, thorough resolution of issues.
  • Oversee the investigation lifecycle to ensure critical rigor, including the deployment of structured problem-solving methodologies (e.g., 5-Why, Fishbone/Ishikawa, DMAIC, Fault Tree Analysis).
  • Establish and monitor mandatory Verification / Effectiveness Checks (VoE) to confirm that corrective actions systematically eliminate recurrence and do not adversely impact device safety or performance.
• Management Reporting & Executive Communication
  • Establish key performance indicators (KPIs) and operational SLAs for the NC/CAPA lifecycle (e.g., cycle times, aging rates, reoccurrence rates, root-cause categorization, effectiveness success rates) to proactively identify systemic risk trends.
  • Communicate quality risks, resource bottlenecks, and compliance vulnerabilities transparently to the Senior Director of Quality and operational business unit heads.
  • Aggregate, trend, and analyze QMS signals across nonconformances, deviations, testing/release failures, audit findings, and product complaints.
  • Author and present high-impact governance dashboards and comprehensive metric packs for Management Review (per 21 CFR 820.20 / ISO 13485) and Quality Executive Committee meetings.
• Continuous Process Improvement & Operational Excellence
  • Champion continuous improvement initiatives across the QMS, optimizing the electronic Quality Management System (eQMS) workflows to reduce administrative burden while increasing investigative quality and compliance adherence.
  • Lead cross-functional Kaizen / Gemba / DMAIC initiatives alongside Clinical Laboratory Operations, R&D, and Supply Chain to target top root-cause drivers of scrap, invalid assay rates, and analytical rework.
  • Drive enterprise-wide training and competency programs on sound root-cause analysis, technical writing for investigations, and risk evaluation.
• Regulatory Compliance & Audit Readiness (21 CFR Part 820 Focus)
  • Serve as the principal regulatory SME for 21 CFR Part 820.100 (Corrective and Preventive Action) and 21 CFR Part 820.90 (Nonconforming Product), guiding the organization through regulatory transitions (e.g., FDA QMSR integration with ISO 13485:2016).
  • Ensure strict integration between the NC/CAPA system and Risk Management files (ISO 14971), verifying that nonconformances trigger appropriate updates to Hazard Analyses and FMEAs.
  • Represent the NC, Deviation, and CAPA programs as the lead front-room SME during FDA inspections, Notified Body audits, and CLIA/CAP surveys.
  • Ensure audit readiness.
• Other responsibilities assigned by Leadership.

Experience & Technical Skills

• Experience Level: Minimum of 8 - 10+ years of progressive Quality Assurance / Quality Systems experience in an FDA-regulated in vitro diagnostic (IVD), medical device, and / or clinical laboratory environment, with at least 4+ years in a formal program management or supervisory/leadership capacity.
• Regulatory Proficiency: Solid command of 21 CFR Part 820, ISO 13485:2016, and ISO 14971; working familiarity with CLIA '88, CAP, NYS CLEP, and IVDR (EU 2017/746) is highly preferred.
• eQMS Leadership: Demonstrated track record configuring, optimizing, and administrating enterprise eQ