Ready to redefine what's possible in molecular diagnostics?

Join a team of brilliant, passionate innovators who wake up every day determined to transform healthcare. At BillionToOne, we've built something extraordinary—a culture where transparency fuels trust, collaboration drives breakthroughs, and every voice matters in our mission to make life-changing diagnostics accessible to all. We don't just aim for incremental improvements; we strive to build products that are 10x better than anything that exists today. Our people are our greatest asset: talented scientists, engineers, sales professionals, and visionaries united by an unwavering commitment to changing the standard of care in prenatal and cancer diagnostics. This is where cutting-edge science meets human compassion—every innovation you contribute helps remove fear of unknown from some of life's most critical medical moments. If you're driven by purpose, energized by innovation, and ready to help build the future of precision medicine, this is where you belong.

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. This role is an onsite role in Union City, CA and will report directly to the Vice President of QARA.

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

Qualifications:

• 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-Haves:

• 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 And Perks:

• 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)

At BillionToOne, we are proud to offer a combination of a (1) base pay range (actual amount offered is based on experience and salary/equity options split that the candidate chooses), (2) generous equity options offering, (3) corporate bonus program, on top of (4) industry leading company benefits (free healthcare options, 401k match, very generous fully paid parental leave, etc.).

For this position, we offer a total compensation package of $390,122 per year, including a base pay range of $216,481 - $237,601 per year.

BillionToOne is an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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About BillionToOne

BillionToOne is a next-generation molecular diagnostics company on a mission to make powerful, accurate diagnostic tests accessible to everyone. Our revolutionary QCT molecular counting technology enhances disease detection resolution by over a thousandfold using cell-free DNA—a breakthrough that's already transformed the lives of over half a million patients worldwide.

Our Impact: We've pioneered game-changing diagnostic solutions that are redefining industry standards. Unity Complete™ stands as the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. In oncology, our Northstar® liquid biopsy test uniquely combines treatment selection with real-time monitoring, giving oncologists unprecedented precision in cancer care.

Our Growth: From $0 to $125 million in Annual Recurring Revenue in just four years. We've raised close to $400 million in funding, including a $130 million Series D round in June 2024, achieving a valuation of over $1 billion. This backing comes from world-class investors including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest.

Our Recognition: Forbes recently named us one of America's Best Startup Employers for 2025, and we were awarded Great Place to Work certification in 2024—with an incredible 100% of our people reporting they are willing to give extra to get the job done. These honors recognize not just our innovation but the exceptional culture we've cultivated—one that remains authentically collaborative and transparent even as we've scaled.

Our Future: Headquartered in Menlo Park with facilities in Union City, California, we're continuing to push the boundaries of what's possible in molecular diagnostics. Recent clinical outcomes data for Unity Fetal Risk Screen and new advances in cancer diagnostics prove we're just getting started.

At BillionToOne, you'll join a diverse team of passionate innovators who believe that the best science happens when brilliant minds collaborate openly, think boldly, and never lose sight of the patients whose lives depend on our work.

Ready to help us change the world, one diagnosis at a time?

Learn more at www.billiontoone.com