Senior Auditor, Quality Assurance - Quality & Compliance QI/CAPA team at ICON plc

Responsibilities and Qualifications:

Independently conducts the following activities as assigned by Quality & Compliance (Q&C) management:

• Manage Quality Issues.
• Lead Quality Issue Investigations.
• Supports Operations in Root Cause Analysis and CAPA Plan preparation.
• Support Effectiveness Check development and outcomes.
• Manage CAPAs resulting from Sponsor Audits, Inspections and/ or Internal Audits.
• Assist with the implementation and maintenance of an effective Quality Management System/Quality Assurance program within the relevant Quality & Compliance (Q&C) team.
• Support business development activities and Q&C initiatives as needed.
• Read, write and speak fluent English.

What you will have:

• 6+ years’ experience working in a clinical, regulatory, pharmacovigilance, or quality environment within CRO/pharmaceutical/healthcare industry.
• Advanced knowledge of GCP (Good Clinical Practice).
• Excellent organizational skills.
• Knowledge of internal auditing standards.
• Must possess a technical knowledge that is applicable to clinical drug development.
• An undergraduate degree, its international equivalent in the sciences, technology, auditing, etc. from an accredited institution or sufficient previous experience in auditing is required.
• Experience in investigator site, vendor, and process audits.
• Open to occasional travel, if required
• Excellent knowledge of MS Office (including Microsoft Word, PowerPoint and Excel).
• Critical thinker that sees the "big picture" (e.g. overall themes, trends, goals), generates innovative ideas and solutions to problems and makes recommendations in the face of complexity, conflicting pressures and ambiguous circumstances.
• Professional communicator, able to gain and maintain a trusted relationship while delivering difficult messages
• Team worker, able to listen to others but also influence in order to see the wider picture and achieve a vision