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Added 3 mins ago
BP
Electrical Engineer
Bonneville Power Administration
Vancouver, WA
- $130,328 to $157,607 USD / year
…transmission system and providing guidance for asset investment…
Added 3 mins ago
BP
Electrical Engineer
Bonneville Power Administration
Vancouver, WA
- $130,328 to $157,607 USD / year
…transmission system and providing guidance for asset investment…
Added 8 mins ago
NG
Director of Audience, Insights, Research and Evaluation
National Gallery of Art
Washington, DC
- $143,913 to $187,093 USD / year
…of its audiences and applies that knowledge to institutional strategy, decision-making, and continuous…
Added 8 mins ago
VH
Student Trainee (Psychology)
Veterans Health Administration
Cincinnati, OH
- $64,290 to $83,582 USD / year
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Added 13 mins ago
IR
Supervisory Human Resources Specialist
Internal Revenue Service
IRS Nationwide Locations
- $125,776 to $197,200 USD / year
HCO - Strategy, Data and Optimization BSP & Governance
Added 13 mins ago
VH
Management & Program Analyst
Veterans Health Administration
Washington, DC
- $121,785 to $158,322 USD / year
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Added 43 mins ago
Senior Product Manager, Agentic Search
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Added 1 hour ago
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Jobgether
Remote, United States
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Added 1 hour ago
Marketing Manager, Advanced Leadership I
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This is a broad, integrated marketing role offering the selected candidate meaningful and gratifying impact on program growth and development through the combination of strategic planning…
Added 1 hour ago
Events Manager
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Added 1 hour ago
EC
Commercial Engineer and Codes & Standards Manager
Eaton Corporation
Ellisville, MO
- $146,000 to $215,000 USD / year
The primary function of the Commercial Engineering and Codes & Standards Manager is to lead Bussmann's customer-facing technical organization and its codes & standards agenda: winning…
Added 2 hours ago
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Staff/Senior Staff Technical Program Manager, Federal
Jobgether
Remote, United States
- $220,000 to $260,000 USD / year
…steps. Our partner is looking for a Staff/Senior Staff Technical Program Manager, Federal based in the United…
Added 2 hours ago
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Manager, Experience Cloud Specialists
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Remote, United States
- $104,000 to $135,000 USD / year
The Manager, Experience Cloud Specialists will lead and develop a high-performing team responsible for driving customer adoption, platform modernization, and revenue growth across the…
Added 2 hours ago
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EverCommerce - Talent Acquisition Operations Manager
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Remote, United States
- $130,000 to $150,000 USD / year
The Talent Acquisition Operations Manager will play a key leadership role in optimizing recruitment operations and strengthening the overall talent acquisition strategy within a…
Added 2 hours ago
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Program Manager
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Santa Cruz, CA
- $83,388.76 USD / year
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Added 2 hours ago
Customer Success Manager
IHS GLOBAL INC
Houston, TX
The customer success manager plays a key-role in helping to secure renewals, close new business and deepen our relationships with clients. By developing an understanding of the users and…
Added 2 hours ago
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Adaptive Planning & Source Protection Manager (Environmental Regulatory Manager)
City of Portland
Portland, OR
- $136,884.8 to $193,086.4 USD / year
Manage the bureau’s Adaptive Planning Program, including convening cross-bureau stakeholders, evaluating supply and demand data, facilitating annual workshops with 40+ participants, and…
Added 2 hours ago
Program Manager, AFCAP VI
Jobgether
Remote, United States
This position is listed on behalf of a partner company, which manages all applications and next steps. Our partner is looking for a Program Manager, AFCAP VI based in the United States.
Added 2 hours ago
WS
(USA) Senior Manager I, Operations Improvement, Facility
Wal-Mart Stores East, LP
Statesboro, GA
- $116,000 to $174,000 USD / year
Manages processes and procedures for areas of responsibility by analyzing data in order to identify existing standards processes governance and work flows evaluating key business components…
Added 3 hours ago
Market Manager, Project Management
Agoda
NY
…performance, and support key regional initiatives. Leveraging data, market insights, and partner feedback, you will help shape supply strategies, optimize marketing program adoption, and…
Added 3 hours ago
Channel Marketing Specialist
Drucker Diagnostics
Port Matilda, PA
…for Drucker Diagnostics. This role helps translate product strategy and customer insights into high-quality campaigns, content, sales tools, and measurable commercial…
Added 3 hours ago
Channel Marketing Specialist
Drucker Diagnostics
State College, PA
…for Drucker Diagnostics. This role helps translate product strategy and customer insights into high-quality campaigns, content, sales tools, and measurable commercial…
Added 3 hours ago
J
Commercial Manager
Jobgether
Remote, United States
- $105,000 to $115,000 USD / year
As Commercial Manager, you will help shape commercial strategy and drive revenue growth across a diverse portfolio of airports and transportation businesses. You will provide strategic and…

Personalis, Inc

Sr. Manager / Associate Director, Quality Events

Fremont, CA, United States

$165,000 to $210,000 USD / year

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Job details

Pay: $165,000 to $210,000 USD / year
Posting language: English
Posted: Nov 6, 2026

Original job description

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:

As 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.

• Ensure audit readiness.

• 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.)

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