Clinical Quality Operations Manager - Remote

Laboratory Animal Management Association

Base: $142,400.00 - $224,100.00; bonus/equity: eli...
Hybrid
Clinical quality management
Inspection readiness
Risk-based approach
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 as it relates to Good Clinical Practice (GCP) inspections by regulatory agencies 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: Medical, dental, vision, retirement, paid holidays, vacation, sick days

Skills & Requirements

Must-have

  • Clinical Quality Management
  • Inspection Readiness
  • Risk-based approach
  • Vendor Oversight
  • GCP/ICH knowledge

Nice-to-have

  • Strategic thinking and creativity
  • Conflict resolution expertise
  • Proactive advice and guidance
  • Process improvement strategies

Key Requirements

  • Minimum 6 years clinical research
  • Minimum 2 years developing clinical quality systems
  • Minimum 2 years managing regulatory inspections
  • Expert knowledge of GCP/ICH
  • BA/BS or MA/MS degree

Work Rights

Not specified

Tailored Resume

Cover Letter