Senior Director, Quality

Location:        Hybrid with Onsite Availability in Boulder Colorado preferred

(Remote may be considered for qualifying candidates.)

About Our Company

Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University. Our approach enables the earlier detection of smaller tumors, leading to more personalized and effective cancer treatment strategies for patients. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth. Foresight Diagnostics is headquartered in Boulder, Colorado.

About The Role

The Senior Director, Quality will create and maintain a quality culture throughout the company including the ownership of the Quality Plan in collaboration with Executive Leadership. Reporting to the Chief Compliance Officer, this role will be primarily responsible for leading the Quality department to partner cross functionally with the Laboratory Director, Clinical Laboratory, Operations, and Software to develop and maintain the processes required for compliance of clinical products in the CLIA laboratory. This role will also lead the development of quality processes to ensure that all products and services are designed and developed in compliance with applicable regulations including CLIA/CAP, US FDA and EU EMA. This role provides strategy, decision-making, leadership, planning, and prioritization to meet the business and compliance/quality objectives.

What You Will Do

• Develop, implement, maintain and continually improve the quality strategy and Quality Management System ensuring compliance with applicable regulations, industry standards, and company policy.

• Drive the strategic planning process for the Clinical Quality Assurance organization through ongoing assessment of regulatory, industry, technology, and clinical trends and best practices.

• In partnership with the Laboratory Director, oversee all aspects of quality assurance and compliance within the laboratory.

• Ensure accurate test results and adherence to regulatory standards such as CLIA, CAP, NYDOH, relevant ISO standards such as 15189, 13485, 14971, 62304, the Code of Federal Regulations, and IVDR.

• Establish and maintain robust quality standards including quality manual and related standard operating procedures. Ensure these systems are effectively communicated, understood, and followed by relevant stakeholders.

• Develop and implement risk management strategies to identify, assess, and mitigate risks associated with clinical patient testing and product development.

• Support regulatory inspections, ensure preparedness, and appropriate responses to findings and observations.

• Ensure products are developed according to design principles and appropriate regulations.

• Developing resourcing and hiring plans for the Quality Team.

• Direct management of quality team employees.

• Work with site lead to provide leadership and oversight for training programs.

• Perform other duties as assigned.

What You Will Bring

Required

• Master’s degree or PhD degree in an applicable field.

• 10+ years of professional experience, with at least 3 years of experience overseeing quality in clinical laboratory with CAP accreditation.

• Proven track record of building and developing a team.

• Experience leading audits by regulatory bodies.

• Demonstrated ability to develop a quality system.

• Experience with regulated product development.

• Experience as the Quality Management Representative.

Preferred

• Experience as the Person Responsible for Compliance under IVDR.

• Experience in Regulatory Affairs.

• Experience leading cross functional teams to deliver business objectives.

Physical Requirements

This position requires the ability to communicate clearly and accurately verbally and in writing, to sit for extended periods, stand, and walk, and to utilize basic office equipment including a computer, keyboard and mouse. This position will lift up-to 10 pounds regularly, and up to 20 pounds occasionally. The position works in a climate-controlled environment, primarily indoors in a