Sr. Manager / Associate Director, Quality Events

The role

This leader provides strategic leadership and program governance over Nonconformance, CAPA, Planned Deviation, and Quality Investigation systems. The role ensures compliance with FDA and ISO regulatory requirements and drives continuous process improvement across the organization.

What you will do

• Provide end-to-end program oversight and governance for global NC, PD, and CAPA systems.
• Chair and direct the cross-functional CAPA & Quality Review Board.
• Oversee the investigation lifecycle using structured problem-solving methodologies.
• Establish and monitor mandatory Verification / Effectiveness Checks.
• Establish key performance indicators and operational SLAs for the NC/CAPA lifecycle.
• Communicate quality risks and compliance vulnerabilities to leadership.
• Aggregate, trend, and analyze QMS signals.
• Author and present governance dashboards and metric packs for Management Review.
• Champion continuous improvement initiatives across the QMS.
• Lead cross-functional Kaizen, Gemba, or DMAIC initiatives.

Required qualifications

• 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
• 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 track record configuring, optimizing, and administrating enterprise eQMS platforms
• Proven success defending CAPA, Deviation, and Nonconformance files directly in front of FDA investigators and ISO/Notified Body auditors
• Exceptional communication, data visualization, and technical writing skills
• Ability to manage multiple priorities and meet agreed-upon timelines

Nice to have

• Working familiarity with CLIA '88, CAP, NYS CLEP, and IVDR (EU 2017/746)

Benefits

• medical
• dental
• vision
• 401(k) match
• ESPP
• tuition reimbursement
• sick/vacation time
• commuter benefits/ EV charging stations
• onsite gym
• wellness benefits

About the company

Personalis is based in Fremont, California and aims to transform the active management of cancer through breakthrough personalized testing.