Clinical Quality Operations Manager, Oncology

Job Description: 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 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 #J-18808-Ljbffr MSD