Senior Manager, Biostatistics
Gilead Sciences
Google Cloud Platform
Associate Director, Clinical Compliance
GRAIL
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $164,000 - $205,000 per year
Job Level
Senior
Tech Stack
Google Cloud Platform
About the role
- Lead and manage internal processes and systems, clinical and diagnostic quality audits, investigator sites and service provider audits, and gap assessments
- Identify areas of compliance vulnerability in clinical and CDx pipelines and develop/drive corrective and preventive action plans
- Provide routine clinical compliance support to clinical study and CDx project teams ensuring adherence to ICH E6 (GCP), relevant diagnostic regulations, and internal quality standards
- Support and lead risk assessment and mitigation strategies for clinical studies and CDx programs
- Lead and continuously refine the organization’s inspection readiness framework for clinical studies and companion diagnostic development across global and regional regulatory inspections (BIMO, pre-approval, GCP, CLIA, IVDR)
- Conduct inspection readiness training and coaching sessions
- Serve as primary point of contact for hosting inspections/audits, drafting and tracking responses to findings, driving resolution, and leading post-inspection lessons-learned initiatives
- Revise, develop, and maintain procedures within the Clinical Quality Management System leveraging lessons from inspections, audits, and emerging compliance trends
- Contribute to, implement, and continuously improve quality management policies and processes related to clinical studies, laboratory-developed tests, and companion diagnostic programs
- Own and maintain GCP audit program SOPs and templates
- Review and provide compliance advice on SOPs, processes, and protocols for clinical trial and companion diagnostic activities to ensure consistency with GCP, CLIA, FDA/IVDR, and other global diagnostic regulatory requirements
- Serve as subject matter expert and provide leadership, expertise, and guidance in clinical and companion diagnostic compliance to internal and external stakeholders
- Promote a culture of quality and clinical compliance and collaborate with cross-functional teams and senior leaders to establish inspection norms and foster continuous improvement
Requirements
- Bachelor’s degree or higher in a scientific, health, quality, or regulatory discipline (advanced degree preferred)
- 10+ years relevant experience in clinical quality assurance, diagnostics, and/or regulatory compliance within diagnostics or medical device
- Experience supporting regulatory inspections such as BIMO and managing GCP and/or CDx inspection and audit preparation and response
- Expert knowledge of applicable regulations and standards related to clinical trial conduct (e.g., ICH E6 (GCP), ISO 20916, ISO 14155, IVDD/IVDR, 21 CFR Part 812 and Part 11)
- Experience managing GCP quality processes such as Quality Events and CAPAs and participating in risk management activities
- Experience conducting GCP audits of internal processes, clinical investigator sites, and clinical service vendors
- Demonstrated ability to initiate process improvements and take initiative
- Strong influencing skills and ability to work collaboratively and cross-functionally in a fast-paced startup environment
- Ability to drive and manage change with a positive approach
- Willingness to travel up to 20%
