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, and ensuring adequate vendor oversight while proactively embedding quality into sponsored trials.
• The incumbent will be responsible for 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: Medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Key Requirements

• 6+ years clinical research experience
• 2+ years developing clinical quality systems
• 2+ years managing regulatory inspections
• Expert knowledge of GCP/ICH

Work Rights