Process, Training and Execution Lead
ICON · Blue Bell
QualityFull-timeCompany career page
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Role summary
ICON Strategic Solutions seeks a Manager of Quality Assurance to lead quality and compliance efforts in clinical trial operations. This role involves developing quality strategies, conducting regulatory audits, and supporting team capability within a sponsor-dedicated model.
What they're looking for
- Bachelor's degree in a relevant discipline
- Minimum 5 years quality assurance experience in pharmaceutical, biotechnology, or CRO settings
- Knowledge of ICH-GCP, FDA regulations, and clinical trial governance
- Strong analytical and problem-solving capabilities for quality issue resolution
- Excellent cross-functional communication and stakeholder collaboration skills
- Willingness to travel approximately 35% as required
What you'll be doing
- Develop and implement quality assurance strategies and processes for clinical trial activities
- Conduct quality assessments and audits to verify regulatory compliance and guideline adherence
- Collaborate with project teams to identify quality issues and execute corrective actions
- Provide guidance to staff on quality policies, procedures, and industry best practices
- Contribute to quality management system development and documentation maintenance
Privacy & handoff
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