Sr. Manager / Associate Director, Quality Events

Personalis•Fremont, CA

1d•Hybrid

About The Position

Personalis is seeking a Sr. Manager / Associate Director of Nonconformance & CAPA Management to provide enterprise-level ownership, strategic leadership, and program governance for the company’s Nonconformance (NC), Corrective and Preventive Action (CAPA), Planned Deviation (PD), and Quality Investigation systems. The role serves as the subject matter expert for applicable FDA, ISO, CLIA/CAP, and global in vitro diagnostic regulatory requirements, and drives the organization toward proactive, data-driven quality prevention. The position partners across Clinical Laboratory Operations, Assay Development, and Manufacturing/Supply Chain, presents quality metrics to executive leadership, and champions continuous improvement. It reports to the Sr. Director of Quality Assurance. This is a hybrid position, with Monday and Tuesday onsite and additional onsite days as needed. The stated hiring range is $165,000 to $210,000 per year. The offered base pay may vary based on geographic region, internal equity, job-related knowledge, skills, and experience. Full-time regular positions also include an annual performance-based bonus or sales incentive plan and long-term incentive units (equity), along with benefits that depend 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.
Ability to influence cross-functional leaders without direct authority.
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 the global Nonconformance, Planned Deviation, and CAPA systems, ensuring procedures reflect industry best practices and regulatory expectations.
Chair and direct the cross-functional CAPA & Quality Review Board, supporting robust root-cause analyses, risk-based prioritization, actionable containment, and timely resolution.
Oversee the investigation lifecycle and deploy 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, including cycle times, aging rates, recurrence rates, root-cause categories, and effectiveness success rates.
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.
Author and present governance dashboards and metric packs for Management Review and Quality Executive Committee meetings.
Champion continuous improvement across the QMS and optimize eQMS 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 root causes of 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 the principal regulatory subject matter expert for relevant FDA 21 CFR Part 820 CAPA and nonconforming product requirements, and guide integration of FDA QMSR with ISO 13485:2016.
Ensure the NC/CAPA system is integrated with risk management files under ISO 14971, including appropriate updates to Hazard Analyses and FMEAs.
Represent NC, Deviation, and CAPA programs as the lead front-room subject matter expert during FDA inspections, Notified Body audits, and CLIA/CAP surveys, and ensure audit readiness.
Perform other responsibilities assigned by Leadership.