The CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area, including operational quality management and inspection management
Job Summary
The CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area, including operational quality management and inspection management.
The incumbent will be accountable for the development of quality plans to implement 'quality by design' within clinical development programs, using a risk-based approach.
The CQOM is responsible for maintaining current regulatory inspection knowledge and effectively leading and supporting GCP inspections worldwide.
Matching Summary
The CQOM is accountable for the execution of operational quality activities within the assigned therapeutic area, including operational quality management and inspection management.
Salary
$142,400.00 - $224,100.00; Bonus and long-term incentive eligible; Medical, dental, vision, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
Operational quality management
Inspection management activities
Quality by Design implementation
Risk-based approach
Vendor oversight
GCP/ICH expertise
Nice-to-have
Proactive quality embedding
Effective working relationships
Process improvement strategies
Novel technology knowledge
Strategic and objective thinking
Key Requirements
Minimum 6 years clinical research
Minimum 2 years developing clinical quality systems