Quality Assurance Lead
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Job Summary
To enhance quality across clinical research operations, the full-time remote Quality Assurance Lead will manage quality issue resolution, support CAPA activities, and analyze quality metrics to drive continuous improvement.
Key responsibilities
- Serve as a quality partner to operational teams, providing guidance on quality issue management and risk identification
- Monitor and drive the timely progression of quality issues while escalating risks that may impact compliance and client commitments
- Collaborate with functional teams to develop and implement Corrective and Preventive Actions (CAPAs) for sustainable issue resolution
Required qualifications
- 5 years of experience in a regulatory environment, including GxP roles
- Strong understanding of Quality Management Systems (QMS) and the CAPA process
- Knowledge of Good Clinical Practice (GCP) and GxP requirements
- A bachelor's degree in Life Sciences preferred, or equivalent Life Science experience
- Ability to communicate quality issue summaries to clients and internal stakeholders
Complete Job Description
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