Senior QA Auditor

ICON

The opportunity:

• Leading and supporting external audits of ICON including scheduling, preparation and hosting.
• Leading CAPA management for external audits of ICON and/or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements.
• Leading CAPA management for sponsor audits of ICON, including liaising with ICON operation teams to ensure timely completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the client to deliver responses with in the agreed timelines and respond to any resulting follow-up.
• Leading quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.
• Ensuring CAPAs are formally recorded and reported and actions are documented and followed until resolution.
• Identify and track required effectiveness checks and ensure checks are completed within the required timelines.
• Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.
• Supporting other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary.

To be successful in the role, you will have:

• BSc Degree is required.
• Knowledge/experience in hosting external audits and/or regulatory inspections.
• Knowledge/experience in CAPA management, including performing effective root cause analysis.
• Ability to review and evaluate clinical data/records.
• Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.
• Detailed understanding of drug development and clinical trial process.
• Good problem resolution skills.
• Good planning and organizational skills with the ability to multi-task and prioritize effectively.
• Ability to work efficiently and independently under pressure.
• Ability and willingness to travel on occasion to accommodate the client.
• Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.