Location: On site or hybrid schedule in Boulder, Colorado, United States
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 Manager, Quality Assurance will be responsible for establishing and maintaining quality processes and improvement initiatives for FDA and ISO-regulated products and clinical testing, specifically supporting Foresight's GCP/CLIA laboratory. This role will operationalize quality systems, leveraging your technical knowledge, skill and abilities to ensure regulatory compliance. The Senior Manager, Quality Assurance will also manage internal and external communication with regulatory agencies overseeing the clinical laboratory and ensuring all applications, systems, products and procedures meet defined quality standards. This position will report to the Director of Quality.
What You Will Bring:

• Bachelor's degree in a scientific field
• Minimum of 7 years of experience in an FDA/ISO-regulated environment, including experience with Clinical regulations (CAP/CLIA/NYSDOH for high-complexity laboratory testing)
• Ability to define, scope, map and implement new or improved documented quality processes

• Knowledge of BSL-2 laboratories
• Experience with LIMS, eQMS, and paper-based quality systems
• Excellent verbal and written communication skills, as well as attention to detail and organizational skills

What You Will Do:

• Implement and maintain the necessary programs to support the Quality Policy, the Quality System, and continuous improvement initiatives to ensure compliance with ISO15189, FDA GCP and GLP, CAP/CLIA, NYSDOH, and other US and international regulatory standards.
• Ensure that Quality System elements are in compliance with Clinical, ISO, and FDA regulations, and help to create and/or drive improvements to Policies and Standard Operating Procedures.
• Oversee FDA-regulated design control activities to ensure effective and compliant execution for the Foresight assay and software design.
• Manage design control documentation required for effective DHF/DHR/DMR management.
• Organize and lead the management of NCR/CAPA, complaints, management review, laboratory support, services, processes, reporting, supplier management, document and records control, training, audits, and other QMS responsibilities.
• Define and maintain quality metrics to measure, analyze, and implement processes to monitor and improve quality.
• Identify and evaluate issues and/or gaps in processes and documentation, and propose effective solutions to remediate.
• Host and provide front-room representation during internal and external audits, including CAP, FDA, ISO, and biopharmaceutical companies.
• Manage audit program, including schedule adherence, reviewing audit reports, and following up on required actions.
• Maintain the eQMS and provide document control support.

Team

• Communicate and interact with all levels of the organization including Executive Leadership
• Work effectively with cross-functional teams for problem-solving, product and process improvement
• Cultivate, build and maintain positive and collaborative relationships within the Quality team and cross-functionally
• Operate as a thought leader and hold cross-functional teams accountable to regulatory, quality, scientific, and performance standards to ensure the highest quality for sample integrity
• Leverage leadership skills to motivate, inspire and train staff to engage in quality and adhere to regulations

This role is offering a salary between $155,000-169,000 and is eligible for equity offerings.
Foresight offers benefits including paid vacation, sick time, and parental leave (if applicable), alongside medical, dental, vision, life, disability coverage, flexible spending accounts, and a 401k with company match.
The application deadline for this position is April 5, 2024
You will be working on interesting problems with extremely high impact. We promote the professional development of our employees and will encourage upward mobility within the company for high performing employees. Foresight Diagnostics 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.