VP of Quality Assurance and Regulatory Affairs
Do you want to join one of the fastest-growing molecular diagnostics companies in biotech history, to help transform prenatal and oncology diagnostics, and help impact millions of patient lives?
BillionToOne (Y Combinator S17), ranked at the top 5% of Y Combinator companies with $200M+ in funding from prominent VC firms, has developed a DNA molecular counter that increases the cell-free DNA diagnostics resolution by over 1,000 fold. BillionToOne's prenatal product, UNITY™ is the first and only prenatal screen that directly assesses the baby's risk for common and severe inherited disorders such as cystic fibrosis, spinal muscular atrophy (SMA), and hemoglobinopathies from a single tube of blood from the pregnant mother. BillionToOne's oncology products, Northstar Select™ and Northstar Response™, aim to revolutionize how late stage cancers are treated and monitored.
BillionToOne is looking for a VP of Quality Assurance and Regulatory Affairs to oversee quality systems for compliance with regulatory requirements as well as lead regulatory strategy, submissions, and interactions with CDPH, CAP, HHS, FDA, and other relevant regulatory agencies.
The QA/RA department is mission-critical as an integral interface between all of our departments and works to foster the company's cultural values. QA/RA ensures that the company's innovation and creativity is translated to trusted clinical tests and ensures that going above and beyond for every patient is at the core of every decision. As such, the mission of the QA/RA Department is to build and maintain trust among BillionToOne clinical teams and external regulators to ensure the validity and correctness of BillionToOne clinical results.
You'll work closely with senior leadership to formulate and implement regulatory strategy for paradigm shifting clinical products at the forefront of personalized medicine in prenatal and oncology; work cross-functionally to celebrate and instill a patient-centric quality culture throughout the organization; represent BillionToOne in interactions with external agencies and stakeholders (e.g. biopharmaceutical partnerships); formulate, maintain, and upgrade policies and procedures for maintaining high quality standards while scaling the clinical lab to meet rapid sales growth. The VP of Quality Assurance and Regulatory Affairs is a member of the executive leadership team and reports directly to the Chief Technology Officer.
Responsibilities:
- Develop, implement, maintain, and communicate the Company's quality strategy and programs.
- Create a culture of quality that is patient-centric first and foremost.
- Oversee the maintenance and upgrades of a fit-for-purpose quality management system (QMS), including adherence to requirements set by CLIA, CAP, NYDOH, GMP, GLP, 21 CFR 820.
- Create and execute a plan for ensuring a state of inspection readiness and continuous improvement.
- Ensure that company and departmental SOPs, job descriptions, and training documentation are current, relevant, and appropriately maintained.
- Oversee global regulatory strategy and submissions in compliance with all applicable global regulatory requirements and in alignment with corporate goals.
- Act as a trusted advisor and business partner in balancing risk and opportunity and advise on strategic decision-making.
- Serve as the company representative for the FDA and other relevant external stakeholders, including biopharmaceutical partnerships.
- Collaborate with clinical affairs and R&D teams to develop regulatory strategies which accelerate time to market.
- Proactively identify regulatory risks to company's programs and create mitigation plans.
- Serve as the company subject matter expert and advisor on regulatory trends, guidances and changes.
- Provide training, and interpretation of regulatory guidelines or issues to personnel.
Requirements:
- 10+ years experience with Laboratory Developed Tests, diagnostics and/or medical device products, including hands-on experience in developing and implementing policies and procedures for Quality Assurance and Regulatory Affairs.
- Experience leading CLIA, CAP, FDA, NYSDOH, HHS audits.
- Experience working in a CLIA/CAP laboratory advising on pharmaceutical partnerships
- Experienced with coordination and direct submission activities for a variety of regulatory approvals such as EUA, IDE, 510k, PMA.
- Experience with process design and improvement and with developing systems and continuous improvements on including QMS.
- Thorough understanding of International Conference on Harmonization (ICH), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP) requirements, regulatory compliance (including ISO 13485, ISO 14971, and ISO 62304, FDA 21 CFR Part 820, and reporting.
- Working experience in full-lifecycle engineering programs and processes.
- Excellent verbal and written communicator who can tailor communication style for a diverse set of internal and external stakeholders.
- Start-up experience with diagnostics product development, commercialization, and in particular, liquid biopsies highly preferred.
Benefits and Perks:
- Suite of benefit plans
- Paid Medical, Pregnancy, Parental and Family Leaves
- Retirement savings program with Company contribution
- Competitive pay
- Generous equity package
- Free daily on-site lunches provided from top eateries
- Latest and greatest hardware (laptop, lab equipment, facilities)
- Free on-site EV charging (compatible with all EVs, including Tesla!)
- Working with a team of 'rockstars' who bring out the best in everyone
- The ability to indirectly or directly change the lives of hundreds of thousand patients
- Open, transparent culture that includes weekly Town Hall meetings
- Fast growth tracks - performance reviews every 6 months
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.