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 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 as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide.
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 principles
Risk-based approach
Vendor oversight
GCP/ICH compliance
Nice-to-have
Proactive quality embedding
Cross-functional team leadership
Continuous improvement strategies
Digital data management knowledge
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
Proficiently interact with all levels of specialists & management