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
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, embedding quality into trials, and ensuring adequate vendor oversight.
The incumbent will be responsible for developing quality plans, managing inspection readiness, and facilitating responses to audit and inspection observations.
Matching 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.
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, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
Quality by Design principles
Risk-based approach
GCP/ICH expertise
Regulatory inspection management
Vendor oversight
CAPA management solutions
Nice-to-have
Digital data management knowledge
Cross-functional team leadership
Strategic and objective thinking
Conflict resolution expertise
Key Requirements
Minimum 6 years clinical research experience
At least 2 years developing clinical quality systems
At least 2 years managing regulatory inspections
Profound knowledge of clinical development programs