Director/Senior Director, Quality Assurance

The Opportunity

Our Operations & Strategy team is expanding. We’re looking for a builder and doer, a teammate who is motivated by a mission and wants to put their imprint on a scaling company.

We are looking for a Quality Lead to join our team to ensure testing in our R&D and clinical laboratory is of exceptional quality and accuracy.

In this role you will support us in executing our QMS to ensure continued high quality research and clinical testing. This includes ensuring all the necessary documentation is in place, activities are being conducted in accordance with high quality policies and procedures and that issues that arise are quickly and effectively resolved. You will also support the continued evolution of our quality system as we rapidly grow the scope of our activities to include CDx development programs.

About Us

Founded in 2021, Precede Biosciences is a diagnostic company pioneering a minimally invasive, comprehensive epigenomics platform. Our technology has the potential to profoundly impact the research and development of new medicines and getting the right therapy to the right patient at the right time. More information on our company and platform can be found on our company website and in our recent publication in Nature Medicine.

Our team cares deeply about creating a place where folks can do their best work from the start and have intentionally created an environment that is defined by purpose, teamwork, and excellence. This means nurturing team spirit, facing challenges together, collaboratively solving complex problems, while also ensuring a strong focus on individual initiative, accountability, and delivery.

Our team is based in the vibrant Seaport district in Boston, MA. We value our culture and believe in the power of in-person collaboration. Our team is in-office at least 3 days per week, and our hope is you’ll want to spend this much time with us too.

• You’ll be the first internal Quality hire and will be responsible for leading the quality strategy as well as delivering on the operations, over time, building a team to support you.
• You’ll lead the continued development/improvement, implementation, and maintenance of a comprehensive QMS in compliance with CLIA, FDA, and other relevant regulations and standards.
• You’ll monitor and report on the performance of the QMS, identifying areas for improvement and leading corrective and preventive actions.
• In this role you are the lead boots on the ground for inspections and audits by regulatory agencies (including CLIA and FDA) and partners and for managing responses to any findings or observations.
• Oversee internal and external quality assessments, proficiency testing, and validation studies.
• You will also maintain and oversee accurate records of quality-related documentation, including SOPs, CAPAs, and quality metrics.
• Developing and delivering training programs on quality management principles, regulatory requirements, and laboratory best practices for laboratory staff is also part of this role
• You’ll manage complicated issues, adapt quickly under pressure and effectively interact and communicate across all functions and levels.

• A Bachelor’s degree in a life science discipline (e.g., biology, genetics) or engineering
• A minimum of 5 years of Quality experience within a CLIA laboratory setting (21 CFR Part 820)
• Working knowledge or experience with FDA QSR and ISO 13485 requirements is strongly preferred
• You are a team player who collaborates and wears multiple hats to accomplish team and company goals
• You are dedicated to excellence yet pragmatic enough to effectively balance quality principles, regulatory compliance and business
• You possess an entrepreneurial spirit and thrive in a fast-paced, hyper-growth environment where change is constant and risk taking is a given
• Experience supporting quality for novel and/or NGS liquid biopsy tests at an industry leading liquid biopsy company is preferred.
• Experience with CLSI quality management system standards is a plus

We believe in building an inclusive and balanced team. We also know meeting every single-exact-criteria can get in the way of meeting stellar folks. Please don’t hesitate to apply!

Precede Biosciences is an equal opportunity employer. We do not discriminate in regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, marital status, ancestry, physical or mental disability, veteran status, or any other legally protected.

Please note that we do not accept unsolicited resumes from recruitment agencies and external recruiters. No fees will be paid for such submissions.