accountable for overseeing the strategic implementation of 'quality by design' principles in assigned clinical trials
develop Risk Assessment and Categorization Tools and Quality Plans in partnership with the CTT
facilitate and oversee responses to audit and inspection observations as appropriate
work with peers to analyze data across therapy areas in order to identify signals and trends and develop and implement appropriate process improvement strategies
develop skillsets to recognize and respond to new and emerging risks through technology

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 as well as quality management systems and quality control tools
Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
Has delivered effective CAPA management solutions
Has worked with risk management tools and processes within the clinical quality framework

medical, dental, vision healthcare and other insurance benefits (for employee and family)
retirement benefits, including 401(k)
paid holidays
vacation
compassionate and sick days

Clinical Quality Operations Manager

Key skills