Sr. Manager, Quality CAPA & Nonconformance

Personalis, Inc; Fremont (CA); Hybrid; USD 165,000 - 210,000; Full time

Job summary

Personalis, Inc. in Fremont, CA is seeking a Sr. Manager / Associate Director of Quality Events to lead Nonconformance, CAPA, PD, and Quality investigations.

This role drives enterprise-wide governance, data-driven prevention, and executive-level reporting to ensure regulatory readiness across QA/Regulatory Compliance. The position emphasizes cross-functional leadership, expert SME guidance on 21 CFR Part 820 and ISO standards, and a focus on continuous process improvement within Clinical

Qualifications

• 8–10+ years in FDA-regulated IVD/medical device or clinical lab quality systems.
• Strong command of 21 CFR Part 820, ISO 13485:2016, ISO 14971; CLIA/CAP knowledge preferred.
• Experience leading enterprise eQMS configuration, optimization, and administration.
• Proven track record defending CAPA/NC files in front of FDA/Notified Bodies.
• Excellent communication, data visualization, and technical writing skills.

Responsibilities

• Provide end-to-end governance for NC, CAPA, PD, and QC investigations.
• Chair CAPA & QRB and drive root-cause analyses and corrective actions.
• Oversee investigation lifecycles and ensure effectiveness checks to prevent recurrence.
• Develop and present governance dashboards for Management Review and executive committees.
• Lead cross-functional Kaizen/DMAIC initiatives across ops, R&D, and supply chain.
• Drive training programs on root-cause analysis and risk evaluation.
• Represent NC/CAPA programs during FDA inspections and audits.

Skills

Quality assurance

CAPA management

Regulatory compliance

Program leadership

Data-driven decision making

Tools

ComplianceQuest

Veeva Vault

MasterControl

TrackWise

Qualio

Job description

Personalis, Inc. in Fremont, CA is seeking a Sr. Manager / Associate Director of Quality Events to lead Nonconformance, CAPA, PD, and Quality investigations.

This role drives enterprise-wide governance, data-driven prevention, and executive-level reporting to ensure regulatory readiness across QA/Regulatory Compliance. The position emphasizes cross-functional leadership, expert SME guidance on 21 CFR Part 820 and ISO standards, and a focus on continuous process improvement within Clinical