Job description
BillionToOne is a next-generation molecular diagnostics company dedicated to developing powerful and accurate diagnostic tests that are accessible to all. Our innovative QCT molecular counting technology significantly enhances the resolution of disease detection using cell-free DNA by over a thousandfold. This groundbreaking technology is integral to our product offerings, including one of our flagship products, Unity Complete™, the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from a single maternal blood sample. Leveraging the same molecular counting technology, we’ve expanded our impact into oncology in 2023 with a pioneering liquid biopsy test, Northstar, that combines treatment selection with monitoring. To date, over 500,000 patients have benefited from our innovative and precise diagnostic tests, and our Annual Recurring Revenue (ARR) has grown from $0 to $125 million in the last ~4 years.
BillionToOne has successfully raised close to $400 million in funding, with a notable $130 million Series D round completed in June 2024, resulting in a company valuation of over $1 billion. This funding has come from prestigious global institutional investors, including Hummingbird, Adams Street Partners, Neuberger Berman, Baillie Gifford, and Premji Invest. BillionToOne has recently been recognized by Forbes as one of America’s Best Startup Employers for 2024, highlighting the company’s exceptional work environment and commitment to innovation.
Our team has grown significantly and despite substantial growth, we have successfully maintained the unique culture that has defined BillionToOne from inception, continuing to cultivate a team that is not only diverse and passionate but also innovative. Headquartered in Menlo Park, California, with an additional facility in Union City, California, BillionToOne remains at the forefront of significant advances in molecular diagnostics, evidenced by the recent announcement of clinical outcomes data for its Unity Fetal Risk Screen and new advancements in cancer diagnostics. For more detailed information about BillionToOne and its groundbreaking work, please visit our website at www.billiontoone.com.
As the Director of Quality Management System, 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 remote role (monthly onsite travel is required) 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 assure 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
- 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 $357,408 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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