Key skills
Google Cloud PlatformGCPGoogle CloudRisk Management
About this role
Role Overview
- accountable for the execution of operational quality activities within the assigned therapeutic area
- oversee headquarters clinical quality operations and support clinical trial teams
- embed quality into the Company's sponsored trials
- ensure adequate vendor oversight and address quality issues
- develop quality plans to implement quality by design within clinical development programs
- maintain ongoing inspection readiness
- prepare for, manage and follow up on regulatory inspections
Requirements
- Minimum of 6 years in clinical research
- at least 2 years with developing and managing clinical quality systems and management of regulatory inspections
- profound knowledge and comprehension of clinical development programs, clinical trial processes, quality management systems and quality control tools
- expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
- effective CAPA management solutions
- experience with risk management tools and processes within the clinical quality framework
- B.A./B.S. or M.A./M.S. Degree or equivalent in relevant health care area
- further formal education in quality management or business management is preferred
Tech Stack
- Google Cloud Platform
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days