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, 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 the implementation of an electronic QMS as well as implementing and supporting the operating of Quality Management System processes and associated programs to maintain compliance with applicable regulations (CLIA, CAP, State DOHs, NYS, ISO13485, etc.). You will work closely with cross-functional stakeholders across BillionToOne (e.g. Lab Operations, R&D, Medical Affairs, Finance, HR, Supply Chain, Sales) to manage Quality System initiatives from initial requirements gathering to go-live and continuous improvement. This role is a hybrid position in Union City, CA and will report directly to the Vice President of QARA.

Responsibilities:

• Monitor the entire global quality system to ensure that acceptable levels of performance are maintained by
  • Ensuring that metrics are established to measure quality and ensure that the processes they measure are within established quality standards
  • Leading quality system continuous improvement activities
  • Providing support for management review of the company’s quality systems and metrics
• Lead a team to manage day-to-day maintenance of the quality management system, but also to develop quality programs that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
• Ensures the quality assurance programs and policies are maintained and modified regularly and facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally
• Ensure communication, training, competency assessment and ongoing compliance monitoring with all requirements of BTO’s Quality Management System (QMS) as Quality Systems Manager per NYSDOH Quality Management Systems Standard of Practice 2.
• Review and approve quality records including non-conforming event reports, corrective and preventive action reports, policies and procedures, document change control, deviation reports, etc.
• Lead large company-wide Quality Systems projects such as ISO13485 implementation.
• Oversee programs across various disciplines including cross-functional projects (i.e. Change Control) by
  • Manage all stages throughout assigned projects.
  • Ensure all aspects of the project management lifecycle are well accounted for: scoping, requirement gathering, resource planning, scheduling, assignments and accountability, tracking and delivery.
  • Track, manage, and adjust plans as necessary to ensure successful delivery.
  • Provide regular status reports to stakeholders, sponsors, the enterprise, and others involved in the project.
• Build and grow our internal Quality team as the company grows. Responsible for establishing performance standards, employee coaching and development, determining employee responsibilities, evaluating performance and rewarding as appropriate, disciplining and recommending termination when necessary. Identifies recruits and retains top-notch talent.
• Manage quality personnel and projects to assure compliance with customer and regulatory requirements.
• Develop and lead a highly motivated team who drives change, improves effectiveness of our QMS and ensures product safety & compliance
• Establish and actively manage expectations, provide training and mentoring to drive professional development for team members
• Ability to travel between all corporate site locations
• Completes other duties as assigned

Requirements:

• 8+ years quality leadership experience with a demonstrated ability to lead and manage people and teams
• Experience working in a CLIA environment and ISO13485 environment.
• Ability to work independently and cross-functionally to provide effective updates at executive level
• Detail oriented with well-developed organizational and analytical skills.
• Creative problem solving, flexibility, and good negotiation skills are a must 
• Proven ability to drive results to established timelines and on budget 
• Proven ability to communicate effectively both in writing and verbally with staff at all levels of the organization 
• Must have experience managing remote business activities 
• Must be comfortable and effective acting as a catalyst for change 
• Candidate must be performance and results oriented and be able to develop, motivate and lead effective teams 
• Hard driver, high energy, positive attitude, works well under stress and with ambiguity 
• Detail oriented and critical thinker characteristics are required
• 25% travel required 

Nice to haves:

• Have worked at an organization supporting the quality systems infrastructure build out for a high growth Company
• Experience scaling the Quality function in a fast-paced, start-up environment is a plus.

Benefits And Perks:

• Working with a team of ‘rockstars’ who bring out the best in everyone
• Open, transparent culture that includes weekly Town Hall meetings
• The ability to indirectly or directly change the lives of hundreds of thousand patients
• Multiple medical benefit options; employee premiums paid 100% of select plans, dependents covered at 80%
• Extremely generous Family Bonding Leave for new parents (16 weeks, paid at 100%)
• Retirement savings program including a 4% Company match
• Free daily on-site lunches provided from top eateries
• Latest and greatest hardware (laptop, lab equipment, facilities)
• 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 $355,908 per year, including a base pay range of $213,282 - $234,090 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 500,000 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