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, ensuring adequate vendor oversight, and addressing quality issues.
Responsibilities include developing quality plans for 'quality by design', 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: Medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
Operational quality management
Inspection readiness and management
Quality by Design implementation
Vendor oversight
GCP/ICH expertise
Risk-based approach
Nice-to-have
Proactive quality embedding
Cross-functional team leadership
Digital data management knowledge
Continuous improvement strategies
Key Requirements
Minimum 6 years in clinical research
At least 2 years developing/managing clinical quality systems
At least 2 years managing regulatory inspections
Expert knowledge of GCP/ICH and worldwide regulatory requirements