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Clinical Quality Operations Manager
Location
New Jersey + 1 moreAll locations: New Jersey | Pennsylvania
Posted
90 days ago
Salary
$142.4K - $224.1K / year
Seniority
Senior
Job Description
Clinical Quality Operations Manager
MSD
• 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
Job 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 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
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
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