Sr. Manager / Associate Director, Quality Events

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

Sr. Manager / Associate Director, Quality Events

Fremont, CA

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:

A s 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.

Regulatory Compliance & Audit Readiness (21 CFR Part 820 Focus)

Serve as the principal regulatory SME for 21 CFR Part 820.100 (Corrective and Preventive Action) and 21 CFR Part 820.90 (Nonconforming Product), guiding the organization through regulatory transitions (e.g., FDA QMSR integration with ISO 13485:2016).

Ensure strict integration between the NC/CAPA system and Risk Management files (ISO 14971), verifying that nonconformances trigger appropriate updates to Hazard Analyses and FMEAs.

Represent the NC, Deviation, and CAPA programs as the lead front-room SME during FDA inspections, Notified Body audits, and CLIA/CAP surveys.

Other responsibilities assigned by Leadership.

Experience & Technical Skills:

Experience Level: Minimum of 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, with at least 4+ years in a formal program management or supervisory/leadership capacity.

Regulatory Proficiency: Solid command of 21 CFR Part 820, ISO 13485:2016, and ISO 14971; working familiarity with CLIA '88, CAP, NYS CLEP, and IVDR (EU 2017/746) is highly preferred.

eQMS Leadership: Demonstrated track record configuring, optimizing, and administrating enterprise eQMS platforms (e.g., ComplianceQuest, Veeva Vault, MasterControl, TrackWise, or Qualio).

Inspection Defense: Proven success defending CAPA, Deviation, and Nonconformance files directly in front of FDA investigators and ISO/Notified Body auditors.

Executive Presence: Exceptional communication, data visualization, and technical writing skills, with the ability to influence cross-functional leaders without direct authority.

Excellent ability to manage multiple priorities and meet agreed-upon timelines.

The hiring range for this position is $165,000 to $210,000 per year, which may factor in various geographic regions. The base pay actually offered will take into account internal equity and also may vary depending on the candidate’s geographic region, job-related knowledge, skills, and experience among other factors. Our full-time regular positions also include an annual performance-based bonus (or a sales incentive plan) and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, dependent on the level and position offered.

Personalis is an equal opportunity employer and is committed to the full inclusion of all individuals. As part of this commitment, Personalis will ensure that persons with disabilities are provided with reasonable accommodations. If you need an accommodation to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please let your recruiter know, if/when they contacts you.

Protecting Our Candidates: At Personalis, we value your security. Please note that all official correspondence from our team will come exclusively from @personalis.com email addresses. We will never ask for personal financial information or conduct interviews over text or chat platforms. If you receive a suspicious request, it is likely a scam. We are committed to a safe recruitment experience and actively work with authorities to investigate and prosecute cyber crimes targeting our community.

Personalis is an Equal Opportunity Employer/Minorities/Females/Veterans/Disabilities. Personalis offers a competitive compensation package and benefits including medical, dental, vision, 401(k) match, ESPP, tuition reimbursement, sick/vacation time, commuter benefits/ EV charging stations, onsite gym, and wellness benefits. (For US only, benefits in other countries may vary.)