Quality and Compliance Assessor

Job Summary:

The Quality and Compliance Assessor collaborates with Clinical Research Associate (CRA) line management to perform quality oversight activities, ensuring consistent, high-quality performance in clinical trials. The role involves monitoring, auditing, analyzing oversight data, and providing guidance to improve operational quality across multiple projects and regions.

Key Responsibilities:

• Perform Routine and Non-Routine Monitoring Evaluation Visits (MEVs) and/or Sign-Off Visits (SOVs) as assigned.
• Analyze qualitative oversight data to identify quality improvement signals.
• Conduct root cause analysis of quality signals and develop action plans to implement process and efficiency improvements.
• Identify training needs for CRAs based on aggregated oversight data to meet quality and efficiency standards.
• Conduct training sessions in collaboration with Learning Center of Excellence, Corporate Quality, and Clinical Operations Management.
• Support Clinical Operations in resolving ad hoc or escalated quality concerns within the region.
• Act as a consultant to local/regional operations regarding quality oversight best practices and tools.
• Assist in reviewing Clinical Monitoring SOPs, tools, or templates related to monitoring oversight.
• Perform other work-related duties as assigned.

Qualifications:

• Bachelor's degree in biological science or healthcare-related field required.
• Minimum of 5 years of experience in monitoring or auditing clinical research programs at a CRO, biotech, or large pharmaceutical company.
• Additional experience as a CRA Line Manager, Project Manager, Clinical Team Manager, or Quality Control role preferred.
• In-depth knowledge of ICH/GCP, local regulations, drug development process, and clinical operations.
• Knowledge of multiple therapeutic areas.
• Ability to work independently within a matrixed environment across multiple projects and geographies.
• Strong attention to detail with excellent organizational, documentation, and presentation skills.
• Strong interpersonal and communication skills; ability to identify, analyze, and solve problems.
• Ability to perform root cause analysis.
• Willingness and ability to travel up to 75%, including internationally.
• Proficiency in written and spoken English; additional languages preferred in regional locations.