Senior Auditor, Quality Assurance

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That’s our vision. We’re driven by it. And we need talented people who share it.
If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

Senior QA Auditor – Inspection & Client Audit Management 

Location: Blue Bell, PA

The Inspection Management team are seeking an individual to join them as a Senior QA Auditor position.  This is a great opportunity for someone with a clinical background to develop their career within Quality Assurance.

This is a specialized team responsible for supporting regulatory inspection activities of clients, investigator sites and ICON as well as leading client audits of ICON globally for our clinical, PV and technology services.

The team works with the clients to arrange, prepare for and support regulatory inspections and external audits, liaising with the internal ICON team to ensure the client expectations are met and that the inspection/audit is a success. The team also manage any resulting observations and CAPAs through to closure.

Key responsibilities will include:

• Leading and supporting regulatory inspection activities of ICON, clients and investigator sites including preparation and hosting
• Liaising with ICON Operational Functional Leads and clients to support inspection readiness activities
• Leading and supporting external audits of ICON including scheduling, preparation and hosting.
• Leading CAPA management for regulatory inspections/external audits of ICON, clients and/or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements
• Leading CAPA management for regulatory inspections/external 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 within 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:

• 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.
• Bachelors’ Degree or Equivalent Experience

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Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to yo