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.
The incumbent will be responsible for developing quality plans to implement 'quality by design' within clinical development programs using a risk-based approach and managing regulatory inspections.
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, retirement, paid holidays, vacation, sick days
Skills & Requirements
Must-have
Operational quality management
Inspection readiness and management
Quality by Design implementation
Vendor oversight
GCP/ICH knowledge
Risk-based approach
Nice-to-have
Proactive quality embedding
Cross-functional team leadership
Strategic thinking and innovation
Effective stakeholder relationships
Digital data management expertise
Key Requirements
Minimum 6 years clinical research experience
At least 2 years developing/managing clinical quality systems
At least 2 years managing regulatory inspections
Expert knowledge of GCP/ICH and regulatory requirements