Senior Manager, Quality & CAPA Governance

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) match

ESPP

Tuition reimbursement

Sick/vacation time

Commuter benefits / EV charging

Onsite gym

Wellness benefits

Job summary

Personalis is seeking a Sr. Manager/Associate Director of Nonconformance & CAPA Management to lead enterprise-level NC, CAPA, PD, and Quality Investigation systems.

You will drive data-driven improvements, oversee cross-functional governance boards, and ensure readiness for FDA inspections and global audits. The role focuses on proactive quality management, regulatory compliance, and operational excellence within Clinical Laboratory Operations, Assay Development, and Manufacturing/Supply Chain,

Qualifications

• Minimum 8–10+ years in FDA-regulated IVD/medical device QA
• Strong command of 21 CFR Part 820, ISO 13485, ISO 14971
• Experience configuring and administering enterprise eQMS platforms

Responsibilities

• Provide end-to-end governance for NC, CAPA, PD, and QMS investigations.
• Lead KPI development and executive reporting for quality programs.
• Drive proactive, data-driven quality improvements across functions.
• Represent QA in FDA inspections and Notified Body audits.

Skills

QA/QMS leadership

Regulatory proficiency

eQMS platforms

Executive communication

Project management

Tools

ComplianceQuest

Veeva Vault

MasterControl

TrackWise

Qualio

Job description

Personalis is seeking a Sr. Manager/Associate Director of Nonconformance & CAPA Management to lead enterprise-level NC, CAPA, PD, and Quality Investigation systems.

You will drive data-driven improvements, oversee cross-functional governance boards, and ensure readiness for FDA inspections and global audits. The role focuses on proactive quality management, regulatory compliance, and operational excellence within Clinical Laboratory Operations, Assay Development, and Manufacturing/Supply Chain,