Senior Manager Clinical Quality

Job Summary

A company is looking for a Senior Manager, Clinical Quality.

Key Responsibilities:

• Serve as a GCP Subject Matter Expert and provide quality oversight for clinical trial activities
• Plan, conduct, and report on risk-based GCP audits
• Support the development of TA-specific Quality Assurance plans and oversee key technologies for endpoint data collection

Required Qualifications:

• Doctorate, Master’s, Bachelor’s, Associate’s degree, or High school diploma with relevant experience in Quality Management or related fields
• Minimum of 2 years of experience managing people or leading teams/projects
• Thorough understanding of Clinical R&D activities and Global Regulations
• Experience with Regulatory Submission and Inspection Management procedures
• Capability to understand and articulate technical concepts and literature in spoken and written English