Location: Morrisville,NC, USA
SAGA Diagnostics is a personalized cancer diagnostics and disease monitoring company focused on molecular genetic analysis of circulating tumor DNA (ctDNA). The company's mission is to improve precision cancer medicine, provide more accurate treatment monitoring, and improve patient survival using minimally-invasive liquid biopsy cancer testing services. SAGA's proprietary tests can help patients, oncologists, and drug developers detect actionable mutations, stratify patient groups, and monitor treatment response, residual disease, and disease recurrence at unprecedented sensitivity and scale. SAGA Diagnostics recently established a US operation in Research Triangle Park (RTP) and is looking for a talented and highly motivated Director of Quality Assurance with a strong interest in advancing our mission to revolutionize cancer diagnostics through the use of liquid biopsies. The Director of Quality Assurance will ensure compliance with CAP/CLIA, NYS, GCP/GCLP, and other regulations as needed. This role requires a leader with extensive experience in quality management within the diagnostics industry. You will be a key member of the global SAGA Quality Assurance team, an international multi-site team, where you will be responsible for ensuring compliance with applicable regulatory requirements. We are growing our Quality Assurance Team and this role will collaborate cross-functionally with various departments within the organization, and ensure effective communication and constructive working relationships with colleagues to enable global development of SAGA Diagnostics. This is an exciting opportunity to join a rapidly scaling cancer genomics startup with excellent momentum, international attention, and strong customer traction - where every role is critical. Through cooperation and teamwork, you will have the opportunity to help grow the company and make a real difference for people with cancer worldwide. Responsibilities: Audit Preparation and Management Stay up-to-date with changes in regulations and standards, and implement necessary updates to QA processes. Plan, conduct, and oversee internal and external audits to ensure compliance with regulatory standards. Manage audit findings, develop corrective action plans, and ensure timely resolution of any issues. Perform vendor audits, as needed. Quality Assurance Oversight Ensure compliance with relevant regulatory requirements, including CAP/CLIA, NYS, GCP/GCLP. Conduct company-wide trainings as necessary to ensure others are upholding necessary regulatory standards. Investigate instances of nonconformances and CAPAs. Departmental Performance and Growth Participate in the development of Quality strategic plans and programs aligned with the company's objectives to ensure quality and compliance performance. Monitor and report quality metrics and performance indicators to improve product quality and process efficiency. Prepare and present regular reports on QA activities, performance metrics, and improvement initiatives to management. Collaborate with cross-functional teams to integrate quality assurance into all phases of product development and production. RequirementsMinimum Master's degree in a relevant scientific discipline or equivalent. Minimum of 10 years of experience in quality assurance in CLIA/CAP high-complexity laboratory. Regulatory compliance knowledge including CLIA, CAP, NYS, state requirements, GCP/GCLP, 21 CFR Compliance and ISO 13485. Extensive experience managing regulatory inspections. Strong interpersonal skills including ability to communicate effectively with people individually and in groups; ability to communicate with technical and non-technical colleagues; experience establishing and maintaining effective relationships with leaders and peers. Ability to multi-task, shift priorities, and work in a fast-paced environment. Detail oriented, well organized and ability to find the simple solutions. Benefits The opportunity to develop cutting-edge automation solutions for genomic diagnostics. Generous benefits package including medical, dental, vision, FSA, HRA, and paid parental leave. Membership to SAGA's Equity scheme. Primary location: Morrisville, North Carolina SAGA Diagnostics is an equal opportunity employer, fully committed to achieving a diverse and inclusive workplace that embraces and encourages applicants of every background. The company's policy regarding equal employment opportunity means that all decisions regarding recruitment, hiring, benefits, wage and salary administration, scheduling, disciplinary action and termination will be made without unlawful discrimination on the basis of sex, gender, race, color, age, national origin, religion, disability, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, citizenship status, pregnancy or maternity, veteran status, or any other status protected by applicable federal, state or local law. If you require reasonable accommodation in completing an application, interviewing, or otherwise participating in the employee selection process, please direct your inquiries to ...@sagadiagnostics.com.