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Quality ICM Issue Lead at ICON plc - ApplyBlast

Quality ICM Issue Lead

ICON plc

5 months ago

Remote

Full Time

Senior

0 applicants

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About this role

The Principal Auditor Quality Assurance at ICON leads the management of Quality Events (QE), ensuring thorough investigations within compliance timelines and regulatory requirements. This role involves triaging cases, driving root cause analysis, escalating critical issues to senior management, and overseeing the development of Corrective and Preventive Action (CAPA) plans. The position also focuses on assessing team performance through data analysis and contributing to process improvements in clinical research quality assurance.

Responsibilities

Lead comprehensive investigations for quality events and audits
Perform root cause and gap analysis on critical issues
Escalate significant quality events to senior management
Develop and monitor Corrective and Preventive Action plans
Drive process improvements in case management systems

Skills

Qualifications

BS in related fieldMBA or MS in related fieldRegulatory License

About ICON plc

iconplc.com

Headquarters

South Dublin, Ireland

Company Size

10001+ employees

Founded

1990

View Profile

ICON plc is a global clinical research organisation (CRO) that provides outsourced clinical development and commercialisation services to pharmaceutical, biotechnology and medical device companies. It offers end-to-end drug and device development support — including clinical trial management across phases, data management and biostatistics, regulatory and safety/pharmacovigilance, and commercialisation and market-access services. ICON combines scientific and therapeutic expertise with technology and a scalable global operations network to accelerate development and bring therapies to patients. Clients engage ICON for integrated, experienced CRO support across the full product lifecycle.