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Director of Quality

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BillionToOne

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Location:
United States , Union City

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

216481.00 - 237601.00 USD / Year
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Job Description:

As the Director of Quality, you will be responsible for leading operational quality initiatives that directly support our CLIA-certified laboratory operations. You will drive continuous improvement efforts focused on reducing nonconformances, minimizing deviations, optimizing receiving inspection processes, and implementing robust supplier controls. This role requires a hands-on leader who can work cross-functionally with Lab Operations, Supply Chain, R&D, and other stakeholders to enhance the operational effectiveness of our quality systems.

Job Responsibility:

  • Lead and execute operational quality programs including incident management, material management, supplier management, trending/monitoring, and compliance
  • Drive continuous improvement initiatives by conducting root cause analyses, implementing corrective actions, and optimizing processes to reduce nonconformances and enhance laboratory efficiency
  • Partner directly with Lab Operations, Supply Chain, R&D, and other stakeholders to solve problems and embed quality into daily workflows
  • Serve as subject matter expert for operational quality matters
  • personally lead critical investigations and improvement projects as needed
  • Driving systematic reduction of quality issues through root cause analysis, trend identification, and implementation of sustainable corrective actions
  • Establishing and tracking operational quality metrics (NCR, CAPA, Change Control, Preventive Maintenance, etc.) to drive data-driven decision making
  • Developing risk-based receiving inspection protocols that balance quality assurance with operational efficiency
  • Establishing acceptance criteria and sampling plans for incoming materials, reagents, and consumables
  • Ensuring laboratory quality systems operate effectively to support daily operations
  • Supporting regulatory inspections (CAP, CLIA, state agencies) with a focus on operational readiness
  • Build and develop a high-performing operational quality team
  • provide hands-on coaching, establish performance standards, and foster a culture of accountability and continuous improvement
  • Mentoring team members on quality principles, regulatory requirements, and effective investigation techniques
  • Drive standardization of operational quality processes across laboratory locations (as applicable)
  • Support quality risk assessments for operational changes and new products
  • Completes other duties as assigned

Requirements:

  • 8+ years quality leadership experience in a CLIA-certified laboratory environment with demonstrated ability to lead and manage people and teams
  • Deep understanding of CLIA, CAP, state laboratory regulations (including NYS Clinical Lab requirements)
  • Proven track record of successfully reducing quality issues through systematic improvement initiatives
  • Hands-on experience with supplier quality management, including qualification, auditing, and corrective action management
  • Experience implementing or optimizing quality processes in a regulated laboratory setting
  • Strong analytical skills with ability to analyze quality data, identify trends, and develop data-driven solutions
  • Demonstrated ability to work cross-functionally and influence without direct authority
  • Ability to work independently and cross-functionally to provide effective updates at executive level
  • Detail-oriented with well-developed organizational and problem-solving skills
  • Proven ability to communicate effectively both in writing and verbally with staff at all levels
  • Hard driver with high energy, positive attitude, and ability to thrive in a fast-paced environment

Nice to have:

  • ISO 13485 quality system experience a plus
  • Six Sigma certification (Green Belt or Black Belt)
  • Familiarity with FDA regulations for IVDs
  • Background in prenatal testing, oncology diagnostics, or companion diagnostics
  • Exposure to GMP or GLP environments (pharma, device manufacturing, or clinical trials)
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)
  • Free daily on-site lunches provided from top eateries
  • A variety of perks on campus (state of the art gym, restaurant)
  • Free on-site EV charging (compatible with all EVs, including Tesla)
  • Generous equity options offering
  • Corporate bonus program

Additional Information:

Job Posted:
December 26, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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