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 role involves developing quality plans to implement 'quality by design' within clinical development programs using a risk-based approach and ensuring adequate vendor oversight.
The incumbent will be responsible for maintaining inspection readiness, preparing for, managing, and following up on regulatory 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
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 activities
quality by design
risk-based approach
inspection readiness
vendor oversight
GCP/ICH knowledge
Nice-to-have
proactive quality embedding
cross-functional team leadership
strategic process improvement
digital data management expertise
interpersonal relationship building
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
Experience with risk management tools and processes