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 as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies worldwide.

Matching Summary

Salary

Base: $142,400.00 - $224,100.00; Bonus/Equity: Eligible for annual bonus and long-term incentive; Benefits: Medical, dental, vision, 401(k), paid holidays, vacation, sick days

Skills & Requirements

Key Requirements

• Minimum 6 years clinical research experience
• 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 and regulatory requirements
• Delivered effective CAPA management solutions
• Worked with risk management tools and processes

Work Rights