Sr. Manager / Associate Director, Quality Events

The posting, as Personalis, Inc wrote it

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, re
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ng 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.)

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