Director of Quality Management System

Do you want to join one of the fastest-growing molecular diagnostics startups and be a pioneer for an industry-leader who is impacting the lives of millions?

Come help lead our world-class Quality Assurance & Regulatory Affairs team and bring your career to the next level working alongside some of the most inspiring leaders in the industry.

BillionToOne, ranked at the top 5% of Y Combinator companies with $250M+ in funding from prominent VC firms, has developed a DNA molecular counter that increases cfDNA diagnostic resolution by over 1,000 fold. BillionToOne's first product, UNITY, is the first and only non-invasive prenatal test that can directly screen an unborn baby and assess its risk for common and severe recessive gene disorders and chromosomal abnormalities, as well as fetal sex and fetal antigens, from a single tube of blood from the pregnant mother without paternal testing.

In 2023, BillionToOne launched two liquid biopsy products that will markedly improve oncology treatment and care. With Northstar Select™, clinicians will be able to select cancer therapies that will be most effective to each patient based on their individual genetic makeup. Northstar Response™ will enable clinicians to monitor a patient’s early response to these cancer therapies, by measuring minute changes in their ctDNA, which can reduce ineffective treatments and unwanted toxicity, lower costs, and substantially improve clinical outcomes.

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, 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 and/or programs across various disciplines including cross-functional projects (i.e. Change Control) by
  • Project 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
• 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.
• Experience working in a CLIA 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, on top of (3) 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 $350,000 per year, including a base pay range of $200,000 to $225,000 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.