Sr. Manager / Associate Director, Quality Events

Personalis, Inc•Fremont, CA

2d•$165,000 - $210,000•Hybrid

About The Position

Personalis is seeking a senior quality leader within its Quality Assurance & Regulatory Compliance organization to own and govern the company’s Nonconformance (NC), Corrective and Preventive Action (CAPA), Planned Deviation (PD), and Quality Investigation systems. The role provides enterprise-level strategic leadership and serves as the subject matter expert for compliance with FDA 21 CFR Part 820 / QMSR, ISO 13485:2016, CLIA/CAP, and applicable global in vitro diagnostic requirements. It will drive the organization toward proactive, data-driven prevention, communicate quality metrics to executive leadership, and champion process improvement across Clinical Laboratory Operations, Assay Development, and Manufacturing/Supply Chain. The position leads program governance, investigation quality, effectiveness verification, management reporting, continuous improvement, training, and audit readiness. It serves as the principal regulatory SME for relevant nonconformance and CAPA requirements, integrates quality events with risk management, and represents the programs during regulatory inspections and audits. The position reports to the Sr. Director of Quality Assurance. The role is hybrid, with Monday and Tuesday onsite and additional onsite days as needed. The hiring range is $165,000 to $210,000 per year. Full-time regular positions also include an annual performance-based bonus or sales incentive plan and long-term incentive units (equity), along with benefits dependent on level and position.

Requirements

At least 8–10+ years of progressive Quality Assurance / Quality Systems experience in an FDA-regulated IVD, medical device, and/or clinical laboratory environment.
At least 4+ years in a formal program management or supervisory/leadership capacity.
Solid command of 21 CFR Part 820, ISO 13485:2016, and ISO 14971.
Demonstrated experience configuring, optimizing, and administering enterprise eQMS platforms.
Proven success defending CAPA, Deviation, and Nonconformance files directly before FDA investigators and ISO/Notified Body auditors.
Exceptional communication, data visualization, and technical writing skills, with the ability to influence cross-functional leaders without direct authority.
Excellent ability to manage multiple priorities and meet agreed-upon timelines.

Nice To Haves

Working familiarity with CLIA '88, CAP, NYS CLEP, and IVDR (EU 2017/746).
Experience with eQMS platforms such as ComplianceQuest, Veeva Vault, MasterControl, TrackWise, or Qualio.

Responsibilities

Provide end-to-end program oversight and governance for global Nonconformance, Planned Deviation, and CAPA systems, ensuring procedures reflect industry practices and regulatory expectations.
Chair and direct the cross-functional CAPA & Quality Review Board, overseeing root-cause analysis, risk-based prioritization, containment, and timely resolution.
Oversee investigation rigor and use of structured problem-solving methods such as 5-Why, Fishbone/Ishikawa, DMAIC, and Fault Tree Analysis.
Establish and monitor Verification / Effectiveness Checks to confirm corrective actions prevent recurrence without adversely affecting device safety or performance.
Establish KPIs and operational SLAs for the NC/CAPA lifecycle and use them to identify systemic risk trends.
Communicate quality risks, resource bottlenecks, and compliance vulnerabilities to the Senior Director of Quality and operational business unit heads.
Aggregate, trend, and analyze QMS signals from nonconformances, deviations, testing/release failures, audit findings, and product complaints.
Prepare and present governance dashboards and metric packs for Management Review and Quality Executive Committee meetings.
Champion continuous improvement and optimize electronic Quality Management System workflows to reduce administrative burden while improving investigation quality and compliance.
Lead cross-functional Kaizen, Gemba, and DMAIC initiatives with Clinical Laboratory Operations, R&D, and Supply Chain to address scrap, invalid assay rates, and analytical rework.
Drive enterprise-wide training and competency programs in root-cause analysis, investigation technical writing, and risk evaluation.
Serve as principal regulatory SME for FDA 21 CFR Part 820.100 and 21 CFR Part 820.90, including guidance through FDA QMSR integration with ISO 13485:2016.
Integrate NC/CAPA processes with ISO 14971 risk management files and ensure nonconformances prompt appropriate updates to Hazard Analyses and FMEAs.
Represent NC, Deviation, and CAPA programs as the lead front-room SME during FDA inspections, Notified Body audits, and CLIA/CAP surveys.
Ensure audit readiness.
Perform other responsibilities assigned by Leadership.