CrawlJobs Logo

Quality Assurance Manager - CLIA/CAP Laboratory

10xgenomics.com Logo

10x Genomics

Location Icon

Location:
United States , Pleasanton

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

132800.00 - 179600.00 USD / Year

Job Description:

10x Genomics is establishing its first CLIA/CAP-certified laboratory to bring cutting-edge single-cell and spatial genomic technologies into clinical practice. Reporting to the Head of Quality and Regulatory, the Quality Assurance Manager will play a pivotal role in defining, developing and implementing the lab’s quality infrastructure, ensuring compliance with CLIA, CAP, and state (including California and New York) requirements. This is a hands-on leadership role suited for a quality professional who can independently execute quality assurance (QA) responsibilities during the lab’s early buildout phase and later lead a small QA team as clinical operations scale. The ideal candidate combines deep knowledge of clinical laboratory quality systems with practical, solution-oriented execution in a fast-paced and collaborative environment.

Job Responsibility:

  • Clinical Quality Framework Establishment and Oversight: Implement document control, deviation/CAPA systems, training programs, and internal audit processes compliant with CLIA, CAP, and applicable state and federal regulations
  • Collaborate closely with CLIA and assay development teams to develop and manage SOPs and work instructions
  • Partner with the broader Quality/Regulatory team to integrate the CLIA lab’s quality infrastructure into 10x’s enterprise-wide quality management system (QMS)
  • Establish and track key quality metrics for laboratory operations (e.g., deviations, nonconformances, complaint handling, audit findings, proficiency testing)
  • In partnership with CLIA Lab Director, ensure inspection readiness and execute regulatory submissions (CLIA, CAP, and state licensure)
  • Operational Quality Support: Provide day-to-day quality oversight of clinical laboratory operations, including review and approval of validation plans, QC data, and reports
  • Serve as QA reviewer/approver for method validation, verification, and change control documentation for both laboratory methods and assay software components
  • Ensure effective management of reagents, instruments, and workflow changes per CLIA/CAP requirements
  • Support onboarding and verification of LDTs transferred from Diagnostic Assay Development teams
  • Act as quality liaison with external auditors and partners
  • Team Leadership and Growth: Initially serve as an individual contributor responsible for implementing and maintaining quality processes
  • As sample volume and operations expand, recruit, train, and manage a small team of QA specialists or analysts supporting lab quality activities
  • Foster a culture of compliance, continuous improvement, and scientific rigor
  • Cross-Functional Collaboration: Partner closely with Laboratory Operations, Diagnostic Assay Development, Clinical Bioinformatics, and IT teams to ensure compliant workflows and data integrity
  • Work with Quality and Regulatory leadership to align CLIA/CAP quality practices with 10x’s broader corporate systems and standards
  • Contribute to strategic planning for quality-related resources, tools, and training across diagnostic programs

Requirements:

  • Bachelor’s or Master’s degree in Life Sciences, Medical Laboratory Science, Quality Management, or related field
  • 10+ years of experience in quality assurance within a regulated clinical laboratory (CLIA/CAP environment)
  • Demonstrated experience building or expanding quality systems in a CLIA lab setting
  • Strong working knowledge of CLIA / CAP quality and documentation requirements
  • Additional knowledge of FDA 21 CFR Part 820 and ISO 13485 strongly preferred
  • Experience preparing for and leading CAP inspections and CLIA audits
  • Excellent written and verbal communication skills, with an ability to collaborate across scientific, operational, and regulatory functions
  • Hands-on, proactive, and adaptable, capable of working effectively in an early-stage, fast-growing diagnostic environment
  • Experience with LIMS, electronic QMS tools, and training management systems is required

Nice to have:

  • A Builder mentality – motivated by creating compliant, fit-for-purpose systems from the ground up
  • Hands-on and detail-oriented, with strong follow-through and accountability
  • Collaborative and pragmatic, balancing regulatory rigor with operational needs
  • Leadership-ready, with the ability to grow into managing a small, high-performing team
  • Mission-driven, passionate about enabling genomic technologies to transform patient care
What we offer:
  • Equity grants
  • Comprehensive health and retirement benefit programs
  • Annual bonus program or sales incentive program
  • Generous time off
  • Competitive and comprehensive health benefits package
  • Easy-to-use benefits that promote wellbeing
  • Family friendly policies like parental leave
  • Award-Winning Workplace

Additional Information:

Job Posted:
January 10, 2026

Employment Type:
Fulltime
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Quality Assurance Manager - CLIA/CAP Laboratory

Laboratory Director/Senior Laboratory Director - Oncology

We are seeking an experienced and highly skilled Molecular Genetics Clinical Lab...
Location
Location
United States , Menlo Park
Salary
Salary:
216481.00 - 264002.00 USD / Year
billiontoone.com Logo
BillionToOne
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Doctoral degree (PhD, MD, or equivalent) in genetics, molecular biology, or a related field
  • Board certification (ABMGG, ABP in Molecular Genetic Pathology, or equivalent)
  • Valid or eligible for California Clinical Laboratory Director license (CGMB, CGMBS, MD/DO licensure) and New York State CoQ in oncology testing
  • 4+ years in a regulated clinical laboratory environment (CLIA/CAP/NYSDOH), with at least 3 years in molecular oncology testing including NGS
  • Proven leadership in developing, validating, and implementing oncology assays (e.g., somatic mutation panels, methylation assays)
  • Deep knowledge of cancer genomics, including tumor heterogeneity, somatic driver mutations, and targeted therapies
  • Experience with variant interpretation databases (COSMIC, OncoKB, ClinVar), IGV, BAM file review, and molecular tumor board participation
  • Strong analytical, communication, and organizational skills, with a track record of leading teams in high-growth environments
  • Proficiency with LIMS and oncology-focused bioinformatics tools
Job Responsibility
Job Responsibility
  • Provide technical oversight to ensure high-quality oncology testing and alignment with laboratory and clinical goals
  • Interpret somatic variant results from Northstar liquid biopsy assays, classify variants, and sign out oncology clinical reports
  • Troubleshoot technical issues related to oncology workflows, including liquid biopsy sample prep, NGS library preparation, sequencing, and data analysis
  • Evaluate lab performance, implement process improvements, and promote robust quality assurance systems
  • Review Non-Conforming Events and CAPAs to ensure timely resolution of issues impacting oncology test performance
  • Ensure compliance with CLIA, CAP, NYSDOH, and other applicable regulatory standards for oncology assays
  • Oversee accurate documentation of SOPs, validation reports, QC records, personnel competencies, proficiency testing, and report archives
  • Collaborate with bioinformatics, R&D, and medical affairs on assay development, interpretation guidelines, and continuous assay optimization
  • Participate in budget planning and manage lab expenses to ensure financial efficiency while maintaining exceptional quality
  • Support special projects, including scaling new oncology tests, preparing for inspections, and implementing automation
What we offer
What we offer
  • Working alongside brilliant, kind, passionate and dedicated colleagues, in an empowering environment, toward a global vision, striving for a future in which transformative molecular diagnostics can help millions of patients
  • Open, transparent culture that includes weekly Town Hall meetings
  • The ability to indirectly or directly change the lives of hundreds of thousands patients
  • Multiple medical benefit options
  • employee premiums paid 100% of select plans, dependents covered up to 80%
  • Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
  • Supplemental fertility benefits coverage
  • Retirement savings program including a 4% Company match
  • Increase paid time off with increased tenure
  • Latest and greatest hardware (laptop, lab equipment, facilities)
  • Fulltime
Read More
Arrow Right
New

Head of Data Analytics & AI

This is a pivotal leadership hire for an award-winning global Food & Beverage or...
Location
Location
United Kingdom , London
Salary
Salary:
110000.00 GBP / Year
triarecruitment.com Logo
TRIA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Proven experience leading Data Analytics and/or AI functions and delivering impactful, large-scale analytical initiatives
  • A strong technical grounding in analytics and data science (Python, SQL, modern data platforms), combined with the ability to operate strategically at leadership level
  • An effective communicator and stakeholder manager, comfortable translating complex analysis into clear, compelling business insight
Job Responsibility
Job Responsibility
  • Defining how Data Analytics and AI are applied across the organisation
  • Building and leading a high-performing team
  • Owning the Data Analytics & AI vision and roadmap across the business
  • Partnering closely with senior stakeholders to embed data-led decision-making and prioritise high-impact initiatives
  • Shaping scalable analytics and AI capabilities from the ground up
  • Setting technical standards, developing talent, and fostering a culture of innovation
What we offer
What we offer
  • 30% Bonus
  • Fulltime
Read More
Arrow Right
New

Store Manager in Training

Store Manager in Training position at Circle K. The role involves leadership and...
Location
Location
United States of America , Homewood
Salary
Salary:
Not provided
https://www.circlek.com Logo
Circle K
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School diploma or GED preferred
  • Experience in retail sales preferred
  • Experience to perform the essential duties, responsibilities and working in the conditions described
  • Ability to supervise and train for the use of equipment, tools and materials listed in the Customer Service Representative (CSR) and Assistant Site Manager (ASM) job description
  • Ability to supervise and manage the functions listed in the CSR and ASM job description
  • Ability to use computer, or acquire those skills necessary to use a computer at the site, which includes analysis of reports, inventory control, cash control, counseling notices, etc.
  • A valid driver’s license and adequate transportation to/from bank and corporate management meetings
  • Ability to communicate (orally and in writing) in English
Job Responsibility
Job Responsibility
  • Recruit, hire and train positive, enthusiastic employees, ensuring excellent customer service
  • Develop, manage and assign tasks appropriately to ensure the site is clean, adequately stocked, organize and well kept based on Company standards
  • Maintain a professional and supportive image among subordinates and supervisor
  • Schedule employees within Company guidelines to maximize customer service and maintain site image
  • Implement non-discriminatory related management skills while hiring, training, counseling, motivating and separating employees
  • Develop positive and professional relationships with all suppliers
  • Promote excellent service and resolve customer complaints in a timely, professional manner
  • Promote and ensure a safe, positive public image within the neighboring community
  • Prepare on-going and timely performance appraisals in writing for all employees, providing proper performance based feedback
  • Train all employees ensuring that customer service, site image and marketing execution meet Company standards
  • Fulltime
Read More
Arrow Right
New

Sr. Associate, Marketing - Premium Products & Experiences

We’re looking for an experienced Marketing Strategist to drive acquisition and c...
Location
Location
United States , McLean; Richmond; New York
Salary
Salary:
87700.00 - 120100.00 USD / Year
capitalone.com Logo
Capital One
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s Degree or Military Experience
  • At least 2 years of experience in brand strategy or product marketing experience with experience managing multiple channels, agency or client side
  • At least 2 years of experience in planning, executing and analyzing marketing programs
  • At least 2 years experience in managing creative processes, partnering with creative teams and developing creative optimization frameworks
Job Responsibility
Job Responsibility
  • Establish brand strategy and foundational elements for existing and new products including design targets, positioning, claims development
  • Develop and execute integrated, multi-channel marketing campaigns on a national scale to drive account growth, brand affinity and customer engagement
  • Shepherd multiple marketing creative projects at once from brief to execution through our process while ensuring strategic intent aligns with execution/delivery at every step
  • Participate as the brand strategy lead in collaborative cross-functional team (business partners, creative teams, legal, compliance, etc) and partner with them to provide strategic and tactical thought partnership to effectively drive project delivery
  • Champion the brand, ensuring that all representation of our products (claims, imagery, card, etc) are in line with their respective brand personas, voice and style guides
  • Leverage problem solving and influencing skills to ensure marketing initiatives deliver on intent
  • Have excellent communication and partnership skills which are essential for interacting and communicating with key stakeholders at all levels across the company to manage, inform and influence outcomes
What we offer
What we offer
  • comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being
  • performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
  • Fulltime
Read More
Arrow Right
New

Maintenance Operative

Your focus as a Maintenance Operative will be to ensure the building and grounds...
Location
Location
United Kingdom , Sheringham
Salary
Salary:
13.50 GBP / Hour
averyhealthcare.co.uk Logo
Avery Healthcare Group Ltd.
Expiration Date
February 16, 2026
Flip Icon
Requirements
Requirements
  • Minimum of one years’ experience in a general maintenance or handy person role and/or hold a professional qualification in a trade
  • Hold a full driving licence
  • Have knowledge of Health and Safety, particularly Moving and Handling techniques, Fire Safety and COSHH assessments
  • Be able to be adaptive and flexible to cover a range of responsibilities at short notice
Job Responsibility
Job Responsibility
  • Carrying out all general maintenance tasks and basic repairs including all electrical, plumbing joinery and building tasks both inside and outside the Home
  • Supporting new residents to arrange their room as they wish
  • Ensuring routine re-decoration is undertaken as required to maintain the standards in the home
  • Advising on the supply and quality of items used to carry out tasks, ensuring the timely and appropriate ordering of replacement goods
  • Providing out of hours emergency service, participating in the on-call rota
  • Fulltime
Read More
Arrow Right
New

Accounts Field Representative

The Field Visit Specialist works proactively with customers to resolve past due ...
Location
Location
United States , Pompano Beach
Salary
Salary:
17.00 - 20.00 USD / Hour
aarons.com Logo
Aaron's
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School diploma or equivalent required
  • 2 years of college or 2 years of previous management experience preferred
  • Collections experience required
  • 2 years preferred
  • Proficient computer skills
  • Strong communication and interpersonal relationship skills both in person and over the phone
  • Ability to work with minimum supervision
  • Excellent organizational skills
  • Safely operate company vehicles
  • keep up with vehicle maintenance
Job Responsibility
Job Responsibility
  • Field Visiting: Carries out all field visit activities of the call center by visiting past due customers in-home, as necessary, to obtain lease renewal payments or secure the return of leased merchandise while maintaining a high level of customer satisfaction
  • Utilizes technology provided to execute the field visit processes
  • Documents all customer appointments and maintains updated and accurate customer information
  • Records electronic customer interactions accurately with every contact
  • Processes payments and posts amounts paid to customer accounts
  • Customer Counselor: Educates the customer on the benefits of timely lease agreement renewal payments
  • Recommends use of components from the full suite of proprietary renewal tools with the intention of assisting customers to ownership
  • Monitors and recommends payment frequency and renewal date changes based on customer payment history and pay dates
  • Vehicle and Protecting Company Assets: Operates company vehicles in a safe manner and in accordance with all applicable laws
  • Conducts daily inspection of assigned delivery vehicles to ensure safety and maintenance guidelines are met
What we offer
What we offer
  • Paid time off, including vacation days, sick days, and holidays
  • Medical, dental and vision insurance
  • 401(k) plan with contribution matching
  • Exclusive discounts on our huge selection of products
  • Work Today, Get Paid Tomorrow!
  • Sundays off
  • Fulltime
Read More
Arrow Right
New

Store Manager in Training

Midwest BU - Region 01 - Market 01: 1160 W Diversey Pky, Chicago, Illinois 60614...
Location
Location
United States of America , Chicago
Salary
Salary:
20.60 - 20.85 USD / Hour
https://www.circlek.com Logo
Circle K
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • High School diploma or GED preferred
  • Experience in retail sales preferred
  • Experience to perform the essential duties, responsibilities and working in the conditions described below
  • Ability to supervise and train for the use of equipment, tools and materials listed in the Customer Service Representative (CSR) and Assistant Site Manager (ASM) job description
  • Ability to supervise and manage the functions listed in the CSR and ASM job description
  • Ability to use computer, or acquire those skills necessary to use a computer at the site, which includes analysis of reports, inventory control, cash control, counseling notices, etc
  • A valid driver’s license and adequate transportation to/from bank and corporate management meetings
  • Ability to communicate (orally and in writing) in English
  • Perform other duties as assigned or delegated by his/her supervisor
Job Responsibility
Job Responsibility
  • Recruit, hire and train positive, enthusiastic employees, ensuring excellent customer service
  • Develop, manage and assign tasks appropriately to ensure the site is clean, adequately stocked, organize and well kept based on Company standards
  • Maintain a professional and supportive image among subordinates and supervisor
  • Schedule employees within Company guidelines to maximize customer service and maintain site image
  • Implement non-discriminatory related management skills while hiring, training, counseling, motivating and separating employees
  • Develop positive and professional relationships with all suppliers
  • Promote excellent service and resolve customer complaints in a timely, professional manner
  • Promote and ensure a safe, positive public image within the neighboring community
  • Prepare on-going and timely performance appraisals in writing for all employees, providing proper performance based feedback
  • Train all employees ensuring that customer service, site image and marketing execution meet Company standards
  • Fulltime
Read More
Arrow Right
New

Manager, Product Management - DevX

Manager, Product Management - DevX. Capital One is a high-tech company, a scient...
Location
Location
United States , Richmond, Virginia; McLean, Virginia; Plano, Texas
Salary
Salary:
149800.00 - 188100.00 USD / Year
capitalone.com Logo
Capital One
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 3 years of experience working in Product Management
  • Currently has, or is in the process of obtaining a Bachelor's or Master's Degree in a quantitative field (Statistics, Economics, Operations Research, Analytics, Mathematics, Computer Science, Computer Engineering, Software Engineering, Mechanical Engineering, Information Systems or a related quantitative field) or an MBA with a quantitative concentration
  • Experience translating business strategy and analysis into consumer facing digital products
  • Technical knowledge and depth necessary to propose and influence new product and feature ideas, especially in the space of automation
  • Analytical and quantitative skills
  • experience using hard data and metrics to back up assumptions and develop business cases
  • Strong verbal and written communication skills with demonstrated experience engaging and influencing senior executives
  • Strong work ethic as team player and a willingness to roll up one’s sleeves to get the job done
Job Responsibility
Job Responsibility
  • Engaging all stakeholders (Engineers, SDLC, Architecture, Risk, and Cyber) directly through a variety of channels to serve as the voice of the customer internally - identifying new capabilities, defining product features, and working closely with development teams to get those features incorporated
  • Interaction with Engineers and understand the technical language to articulate the requirements
  • Drive the product management practice within the organization, defining expectations and commitments
  • Operationalizing product metrics for the products you own and building the business case for new investment
  • Influencing senior stakeholders to use our products and sharing with them the outcomes we are enabling to strengthen investment
  • Envisioning, designing, and delivering best-in-class solutions that improve the quality of life of our software delivery teams while maintaining the highest quality and security standards
  • Defining and executing strategy to improve developer productivity, test automation, and our delivery pipeline
  • Partnering with tech and design partners to deliver tools and strategy on how developers will write, build, and test their code, and leverage test automation on the DevOps pipeline before releasing the code
  • Driving the experience for adoption of development tools, automated testing and provide the quality measure on the developed software
What we offer
What we offer
  • Comprehensive, competitive, and inclusive set of health, financial and other benefits that support your total well-being
  • Performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI)
  • Fulltime
Read More
Arrow Right