BillionToOne · 1 day ago
Director of Quality
Union City, CA
Full-time
Onsite
Director/Executive
$216K/yr - $238K/yr
8+ years expBillionToOne is a next-generation molecular diagnostics company focused on transforming healthcare through innovative diagnostic solutions. The Director of Quality will lead operational quality initiatives to support CLIA-certified laboratory operations, driving continuous improvement and ensuring compliance across various functions.
BiotechnologyGeneticsHealth DiagnosticsMedical
Responsibilities
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
Qualification
Required
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
Preferred
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)
Benefits
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)
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)
Company
BillionToOne
BillionToOne is a precision diagnostics company that focuses on genetic testing for disease detection.
501-1000 employees
H1B Sponsorship
BillionToOne has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (6)
2023 (2)
2022 (2)
2021 (1)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$425.9MKey Investors
Premji InvestBridge BankHummingbird Ventures
2025-11-06IPO
2024-06-21Series D· $130M
2022-12-15Series C· $48.5M
Leadership Team
J
Jean Hayden
VP of Operations and Chief of Staff to the CEO
Oguzhan Atay
Co-founder and CEO
Recent News
2026-01-16
Company data provided by crunchbase