Find work in the United States.

A simpler way to find your next job.

Jobs in the United States

25+ jobs

Save this search

Added 2 mins ago
Technology Delivery Lead - Energy
Accenture
Honolulu, HI
…814,000 people with proprietary assets and platforms, deep process and industry expertise, and leading ecosystem relationships to deliver end-to-end solutions and measurable outcomes at…
Added 2 mins ago
Resource Support Analyst
BOOZ, ALLEN & HAMILTON, INC.
Honolulu, HI
…budgeting, and execution for current and future year planning and development in support of Pacific intelligence operations while imparting your expertise to the…
Added 5 mins ago
SC
Laboratory Technician
Shell Chemical LP
PA
- $72,000 to $108,000 USD / year
Added 22 mins ago
AB
Regional Distribution Center - Warehouse Associate
Asphalt Buyer II LLC
Shafter, CA
- $19 USD / hour
Self-Development - Actively seeking new ways to grow and be challenged using both formal and informal development channels.
Added 23 mins ago
HT
DATA ADMISTRATIVE AIDE DYCD CONNECT PTS/EMS KNOWLEDGE
HANDS THAT MAKE A DIFFERENCE INC
NEW YORK, NY
- $17 to $20 USD / hour
Associate's Degree in Business Administration, Office Administration, Information Systems, Human Services, or a related field preferred.
Added 27 mins ago
LV
GIS Developer (Option to Underfill)
Las Vegas Valley Water District
United States
- $113,486 USD / year
NOTE: The hiring department may consider applicants at the Associate level. If this job class is used to fill the position, the successful candidate will be hired on at the following…
Added 27 mins ago
A
Registered Nurse RN Emergency Department Full-time Nights
AdventHealth
Minneola, FL
- Full-time
…our Clinical Ladder Program based on experience, professional development, and achievement of advancement…
Added 27 mins ago
Certified Medical Assistant Primary Care
Ascension Health
Fleming Island, FL
Career growth: Ascension-paid tuition (Vocare), reimbursement, ongoing professional development and online learning
Added 27 mins ago
B
Seasonal Retail Stocking Associate - Part Time
Burlington
Cape Coral, FL
- $15 USD / hour
- Part-time
…nation, join the Burlington Stores, Inc. as a Seasonal Stocking Associate ! Are you looking for a hands-on role in a fast-paced environment? Do you have great organizational skills and work…
Added 27 mins ago
B
Seasonal Cashier Associate - Part Time
Burlington
Cape Coral, FL
- $15 USD / hour
- Part-time
…the customer's needs while getting them through the check-out process quickly and easily, our cashiers are key in helping us provide a world-class shopping experience to our…
Added 27 mins ago
Certified Medical Assistant Primary Care
Ascension Health
Orange Park, FL
Career growth: Ascension-paid tuition (Vocare), reimbursement, ongoing professional development and online learning
Added 27 mins ago
W
P_0000242831 (USA) Personal Shopper Lead - Sam's
Walmart
Panama City, FL
- $21 to $29 USD / hour
…programs by training and providing resources to meet store associate needs assigning dutiesproviding feedback communicating goals and ensuring associate coverage at the ecommerce pickup…
Added 27 mins ago
B
Retail Stocking Team Supervisor - Full-Time
Burlington
Bradenton, FL
- $17 to $19 USD / hour
- Full-time
You will enjoy a competitive wage, flexible hours, and an associate discount. Burlington's benefits package includes medical, dental, and vision coverage including life and disability…
Added 27 mins ago
PeopleShores ATC - Business Architecture Associate – Columbus/Tampa - NAELFY27
Accenture
St. Petersburg, FL
As Tech Associate, you’ll work alongside experienced architects and developers to help design, configure, and test technology solutions that solve real business challenges for our clients.…
Added 27 mins ago
A
Patient Access Liaison - UPLIZNA- North Florida
Amgen
West Palm Beach, FL
- $158,394 to $222,256 USD / year
Associate’s degree and 8 years of patient services and/or access and reimbursement experience
Added 27 mins ago
Institutional Review Board Specialist I
AdventHealth
Orlando, FL
…researchers, and study teams daily to facilitate the research review…
Added 27 mins ago
B
Seasonal Cashier Associate - Part Time
Burlington
Miami, FL
- $15 USD / hour
- Part-time
…the customer's needs while getting them through the check-out process quickly and easily, our cashiers are key in helping us provide a world-class shopping experience to our…
Added 27 mins ago
S
Liability Claims Associate | Remote | Dedicated Client
Sedgwick
Jacksonville, FL · Tallahassee, FL · Orlando, FL · Tampa, FL · Miami, FL
- $21 USD / hour
Career development and promotional growth opportunities through increasing responsibilities
Added 32 mins ago
CH
Polysomnographic Technologist I (Part Time Nights)
Children’s Hospital of Orange County
United States
- Part-time
…RCH’s compensation structure, benefits offerings, and career development programs are geared to helping you achieve your professional and personal goals. Apply now to see where your career…
Added 34 mins ago
Power Generation Project Engineer (Electrical)
Pacific Gas And Electric Company
Auberry, CA
This is a journey-level Project Engineer job that requires mastery of the Associate level Project Engineer skills and duties and provides complete engineering & design, project management,…
Added 34 mins ago
Senior Director of Graduate Recruitment and Enrollment
Agnes Scott College
Decatur, GA
Reports to: : Associate Vice President and Dean of Graduate Studies
Added 41 mins ago
DO
WATER RESOURCES ENGINEERING ASSOCIATE (SPECIALIST)
Department of Water Resources
CA
- $7,492 to $9,379 USD / month
Duties: Under general direction of the Supervisor of the Operations Reporting Section, the Water Resources Engineering Associate (Specialist) is responsible for analyzing operation data of…
Added 41 mins ago
CD
Senior Tax Auditor
CA Department of Tax and Fee Administration
CA
- $6,646 to $8,740 USD / month
…CDTFA. We value staff and are dedicated to employee career development. Our agency supports the development of staff by offering training to flourish in their position and programs to…
Added 50 mins ago
Senior Director CVO Operations
Ascension Health
Saint Louis, MO
+ Partners with CVO to provide process improvement to services that enhance the experience and turnaround times for stakeholders.
Added 50 mins ago
Executive Underwriter, Property
Allianz Insurance
Chicago, IL
Contribute to the development and execution of the regional underwriting strategy for your Line of Business

Personalis, Inc

Sr. Manager / Associate Director, Quality Events

Fremont, CA, United States

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

Apply About employer

Applications open in a new tab.

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.)

Apply About employer

Report this job