Senior Auditor, Quality Assurance-GCP

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.

The Role:

GENERAL Responsibilities

• Perform tasks relevant to the assigned Quality & Compliance function including but not limited to conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defense, case management and CAPA management.
• Conduct departmental and ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations; mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training.
• Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate.
• Delegate assignments to local Q&C audit staff at the request of Q&C management; provides support and escalates for intervention to ensure staff have the necessary tools to perform requested assignments.
• Liaise with clients and operational persons including managers on quality aspects which may include attendance at meetings, oral presentations and audits.
• Assist with business development activities, including the preparation of contracted audit cost proposals/contracts, and attend marketing presentation, when appropriate.
• Have a thorough knowledge of all relevant SOPs, and appropriate regulations and guidelines.
• Understand key business drivers; uses this understanding to accomplish own work.
• Build knowledge of the company, processes and customers.
• Assume additional responsibilities, which are directed by the Q&C Manager or higher.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.
• Good Clinical Practice (GCP) knowledge around conducting audits is required
• Travel (up to 35%) domestic and/or international, on occasion this may increase based on business needs.  Depending on Q&C function, an Auditor may be requested to complete all/some of the responsibilities listed below under each heading as needed.  

AUDITING Responsibilities:  

• Plan and conduct regular internal audits as well as contract audits (including standalone work) and for cause  audits  of  the  ICON  quality  system  in  order  to  evaluate  the  quality  system  against  the requirements appropriate regulations and applicable guidelines.
• Perform the role of a lead auditor to assess the effectiveness of the quality system and to verify that the quality system is being implemented. Assist with the development of the project audit schedule.
• Perform vendor and sub-contractor audits and follow up of previous findings, as well as validation reviews as required.
• Review audit replies to Q&C. Follow up all outstanding replies and report issues to the relevant management for action.  Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented. Verification of audit CAPA completion where required by procedure.
• Train QA auditors, and provide a standard for auditing to inexperienced or less experienced colleagues.  
• Carry out a senior role in the regional QA department (Project Audits), such as scheduling of audits.
• Operates under moderate supervision and direction and makes decisions frequently that have a direct impact upon the local external and internal audit schedule and the resource allocation for audits within the local department.
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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.

Visit our careers site to read more about the benefits ICON offers.