Senior Auditor, Quality Assurance - With Growth Opportunities

We are searching for an ambitious Senior Auditor, Quality Assurance to join our productive team at ICON in Ciudad de México.
Growing your career as a Full Time Senior Auditor, Quality Assurance is a great opportunity to develop relevant skills.
If you are strong in people management, adaptability and have the right initiative for the job, then apply for the position of Senior Auditor, Quality Assurance at ICON today!

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 – Client Audit Management

Act as a lead host or support member for Client/Sponsor-lead audits in the Audit Defense Team.

Quality Assurance:

The Audit Defense team are seeking a Senior Auditor to join the team. This is a specialized team responsible for hosting client audits of ICON globally for our clinical, PV and technology services. The team work directly with the client auditors to arrange, prepare for and host the external audit, liaising with the internal ICON team to ensure the client audit expectations are met and that the audit is a success. The team also manages any resulting observations and CAPAs which ensures the external auditor has one central point of contact for the duration of the audit through to closure. The Audit Defense team have many years experience of hosting both on-site audits conducted at ICON facility, as well as hosting remote audits using technology available to ensure the audit scope can still be met remotely.

Key responsibilities will include:

• Hosting/leading and supporting external audits of ICON including scheduling, preparation, liaison, 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:

• 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.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours.
We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead.
But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON is an equal opportunity and inclusive employer and 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.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

Benefits of working as a Senior Auditor, Quality Assurance in Ciudad de México:

● Company offers great benefits
● Company offers career progression opportunities
● Attractive package