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: 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.