Director of Quality

BillionToOne•Union City, CA

15d•$216,481 - $237,601•Onsite

About The Position

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.

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 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)

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

Benefits

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)