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 developing quality plans to implement 'quality by design' within clinical development programs using a risk-based approach and ensuring ongoing inspection readiness.
The company offers a comprehensive package of benefits including medical, dental, vision healthcare, retirement benefits, paid holidays, vacation, and sick days.
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, 401(k), paid holidays, vacation, sick days
Skills & Requirements
Must-have
Quality by Design principles
Risk-based approach
GCP/ICH and regulatory requirements
Vendor oversight
Inspection management and follow-up
CAPA management solutions
Nice-to-have
Proactive quality embedding
Digital data management knowledge
Cross-functional team leadership
Strategic problem-solving
Conflict resolution expertise
Key Requirements
Minimum 6 years in clinical research
At least 2 years developing/managing clinical quality systems
At least 2 years managing regulatory inspections
Profound knowledge of clinical development programs
Expert knowledge of GCP/ICH
Experience with risk management tools and processes