Senior QA Auditor
4 weeks ago
At ICON, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a highly skilled Senior QA Auditor to join our Audit Defense team.
The OpportunityThis is a specialized role that involves leading client audits of ICON globally for our clinical, PV, and technology services. As a Senior QA Auditor, you'll work directly with client auditors to arrange, prepare for, and host external audits, ensuring that client audit expectations are met and the audit is a success.
Key Responsibilities- Leading and supporting external audits of ICON, including scheduling, preparation, and hosting.
- Leading CAPA management for external audits of ICON and/or investigator sites, ensuring 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.
- Leading quality issue investigations, 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.
- Identifying and tracking required effectiveness checks and ensuring checks are completed within the required timelines.
- Providing advice and support to operation teams where needed to ensure CAPAs 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.
- 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 clients.
- Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.
Our success depends on the quality of our people. We offer a competitive salary package, annual bonuses, and a range of health-related benefits to employees and their families. We're committed to providing a workplace free of discrimination and harassment, and we welcome applications from diverse candidates.
At ICON, we're passionate about delivering high-quality services that meet the needs of our clients. If you're a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.
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