Job Summary

• The Clinical Quality Operations Manager is accountable for the execution of operational quality activities within the assigned therapeutic area, including operational quality management and inspection management.
• The role involves overseeing headquarters clinical quality operations, supporting clinical trial teams, ensuring vendor oversight, and addressing quality issues proactively.
• The incumbent will be responsible for developing quality plans, maintaining inspection readiness, managing regulatory inspections, and ensuring timely implementation of CAPA management solutions.

Matching Summary

Salary

$142,400.00 - $224,100.00; Bonus and long-term incentive eligibility; Comprehensive benefits package

Skills & Requirements

Key Requirements

• Minimum 6 years in clinical research
• At least 2 years developing clinical quality systems
• At least 2 years managing regulatory inspections
• Expert knowledge of GCP/ICH and worldwide regulatory requirements
• B.A./B.S. or M.A./M.S. Degree or equivalent

Work Rights