Quality and Regulatory Program Manager

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.

We're looking for an experienced and highly strategic Quality and Regulatory Program Manager to lead our quality-focused initiatives and help scale the company through its next phase of growth. In this role, you'll be responsible for overseeing critical quality programs including our Arena QMS implementation, ISO 13485 certification, Companion Diagnostic (CDx) development, Configuration Management (CM) processes and compliance initiatives.

You'll bring structure to ambiguity, establish repeatable processes, and drive alignment across R&D, operations, manufacturing, regulatory, and quality teams. If you love wearing multiple hats, building from scratch, and making a tangible impact in a quality-driven environment, this role is for you. This role is an onsite role in Union City, CA and will report directly to the Vice President of QARA.

Responsibilities:

• Lead the implementation of Arena QMS across the organization, including requirements gathering, configuration, validation, training, and rollout
• Develop and execute a phased approach to QMS implementation, ensuring minimal disruption to ongoing operations
• Oversee the migration of existing quality documentation and processes into the new electronic QMS
• Spearhead our ISO 13485:2016 implementation program from gap assessment through certification
• Develop and execute a comprehensive roadmap for achieving ISO 13485 certification on schedule
• Lead the design and implementation of the entire Configuration Management framework, including identifying and documenting the items to be controlled and the information to be captured and recorde
• Develop, maintain, and implement CM process standards, plans, and procedures. Ensures changes to the process methods and processes are properly approved, communicated and managed throughout the CM lifecycle
• Coordinate cross-functional implementation teams and manage relationships with external consultants/auditors
• Establish procedures for and implement the introduction of changes to engineering documents for an assigned program and represent the functional group in the implementation of common processes
• Review and analyze released engineering change data and coordinates changes with engineering, quality, support, manufacturing, and engineering data control activities
• Ensures implementation of customer and internal configuration management requirements
• Manage change and status activities to ensure compliance with configuration management policies
• Establish and control configuration identification processes and baselines
• Lead quality initiatives related to our CDx development and regulatory approval processes
• Establish and oversee project plans for CDx design verification, validation, and regulatory submissions
• Manage cross-functional teams to execute CDx quality strategies and compliance programs
• Develop comprehensive program strategies with clear objectives, milestones, and success metrics for all quality initiatives
• Establish governance structures and decision-making frameworks for major quality programs
• Provide executive leadership with visibility into quality program status, risks, and outcomes
• Balance regulatory compliance with operational efficiency and speed-to-market
• Lead additional strategic quality initiatives as they emerge with our growing business
• Implement portfolio management practices to prioritize quality initiatives based on strategic value and compliance requirements
• Manage resource allocation and optimize capacity across multiple concurrent quality projects
• Develop standardized methodologies tailored to different quality project types and complexity levels
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