Job Summary

• The Clinical Quality Operations Manager is accountable for the execution of operational quality activities within the assigned therapeutic area, including quality management and inspection management.
• The role involves overseeing headquarters clinical quality operations, supporting clinical trial teams, and ensuring adequate vendor oversight.
• Responsibilities include developing quality plans, managing inspection readiness, and facilitating responses to audit and inspection observations.

Matching Summary

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Comprehensive package including medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Key Requirements

• Minimum 6 years clinical research experience
• Minimum 2 years developing clinical quality systems
• Minimum 2 years managing regulatory inspections
• Expert knowledge of GCP/ICH and regulatory requirements
• Experience with risk management tools and processes
• Proven CAPA management solutions

Work Rights