Senior Manager, Clinical Quality

Job Summary

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

Key Responsibilities

• Review clinical trial protocols to ensure simplification and critical data identification
• Provide quality oversight for risk assessment and ensure patient safety and data integrity
• Develop and implement risk-based Quality Assurance plans and support clinical trial teams in quality management activities

Required Qualifications

• Doctorate degree with 2 years of quality experience, or Master's with 6 years, Bachelor's with 8 years, Associate's with 10 years, or High school diploma/GED with 12 years of quality experience
• Minimum of 2 years of experience managing people or leading teams/projects
• 5 years or more experience in Quality Management or Quality Assurance in the pharmaceutical/biotech industry
• Experience with Quality Management Systems and managing quality in electronic QMS
• Thorough understanding of Clinical R&D activities and Global Regulations