Quality and Regulatory Program Manager

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
• Create and maintain project management tools, templates, and best practices specific to quality initiatives
• Ability to travel between all corporate site locations
• Completes other duties as assigned

Qualifications:

• 5+ years of experience leading complex projects and programs, with significant focus on quality initiatives in regulated environments
• Proven ability to drive clarity, execution, and impact in fast-paced, high-growth environments
• Experience managing cross-functional teams and high-budget quality initiatives
• Strong communication and leadership skills with a collaborative, hands-on approach
• Ability to operate strategically while diving into the details when needed
• Bachelor's degree in a relevant field (science, engineering, business, or related discipline)
• Demonstrated success in implementing electronic quality management systems (Arena experience highly desirable)
• Experience with quality management system standards and regulatory frameworks
• Track record of successfully delivering quality projects on time, within budget, and meeting compliance requirements
• Detail oriented and critical thinker characteristics are required 
• 25% travel required  

Nice-To-Haves:

• Experience working in pre-IPO or rapid-growth startup environments
• Background in medical devices or diagnostics, especially with knowledge of ISO 13485
• Familiarity with CLIA-certified lab operations and quality requirements
• Track record of managing ISO certification programs and electronic QMS implementations
• Experience leading both large program teams and agile project pods
• Professional certifications such as PMP, ASQ CQA, CQE, or RAC
• Experience in molecular diagnostics, life sciences, or related healthcare fields

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%)
• Free UNITY Complete NIPT testing for employees & spouses
• 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 $243,583 per year, including a base pay range of $161,262 - $171,666 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.