Senior Auditor, Quality Assurance

Senior Auditor, Quality Assurance - US, Blue Bell, Office with Flex

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

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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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.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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

ICON, including subsidiaries, 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, colour, 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 or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply