Clinical Quality Operations Manager, FSP
Fortrea · United States · 3 wk ago
RemoteRemoteManufacturingFull-time
Responsibilities
- Operational Quality Management
- Risk-Based Quality Management
- Third Party Oversight
- Data Analysis and Process Improvement
- Inspection Preparation and Management
- Capa Management Support
Qualifications
- Minimum of 6 years of relevant experience in clinical research
- Profound knowledge and understanding of clinical development programs, quality management systems, and quality control tools
- Expert knowledge of GCP/ICH and worldwide Regulatory Health Authority requirements
- Experience with delivering effective CAPA management solutions
- Experience with risk management tools and processes within the clinical quality framework
- Familiarity with on-site monitoring activities, including pre-study, initiation, routine monitoring, and closeout visits
- Detailed knowledge of all aspects of GCP guidelines and regulations
- Demonstrated ability to separate critical from non-critical GCP issues
- Demonstrated ability to balance quality and speed in complex situations
- Strategic thinking, problem-solving, and analytical abilities
- Effective cross-functional collaboration and inspection readiness
- Strong interpersonal and communication skills
- Strong negotiation and influencing skills
- Strong analytical skills
- Excellent planning and organizational skills
- Excellent oral, written, and presentation skills