Compliance Manager
HeadwayFull Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
The Associate Director, Clinical Compliance must have a strong understanding of ICH E6 (GCP) and relevant diagnostic regulations, including CLIA and IVDR. Experience in leading inspection readiness and managing quality management systems is essential. The role requires the ability to identify compliance vulnerabilities, develop corrective action plans, and provide expert guidance on clinical and companion diagnostic regulatory standards and best practices.
This role will lead and manage internal processes, clinical and diagnostic quality audits, and investigator site and service provider audits. Responsibilities include identifying compliance vulnerabilities, developing and driving corrective/preventive action plans, and tracking clinical compliance metrics. The Associate Director will provide routine clinical compliance support, lead risk assessment and mitigation strategies, and refine the organization’s inspection readiness framework. They will also serve as the primary point of contact for hosting inspections/audits, drafting responses, and leading post-inspection initiatives. Additionally, the role involves revising, developing, and maintaining procedures within the Clinical Quality Management System, and contributing to quality management policies and processes for clinical studies, LDTs, and companion diagnostic programs.
Develops blood tests for early cancer detection
GRAIL focuses on improving cancer detection through advanced blood tests that identify cancer at its earliest stages, enhancing treatment success rates. The company utilizes high-intensity sequencing to analyze tumor genome data, employing algorithms and deep learning to extract actionable information for early cancer detection. GRAIL differentiates itself from competitors by its commitment to large-scale clinical studies that validate the effectiveness of its tests. The primary goal is to reduce global cancer mortality by enabling early diagnosis, making the disease more treatable.