Senior Auditor, Quality Assurance

Senior Auditor, Quality Assurance - USA (Home-Based with Travel)

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.

We have an incredible opportunity for a Senior Auditor, Quality Assurance to join ICON’s Full Service Quality & Compliance team. The Senior Auditor, Quality Assurance will conduct investigator site audits and supplier audits in the United States.

Location: USA (home-based) with up to 35% Domestic Travel

What you will be doing:

• Guiding and conducting comprehensive audits of clinical trial processes, systems, and documentation to ensure compliance with regulatory standards and guidelines
• Collaborating with cross-functional teams to identify areas for improvement in quality assurance processes and practices
• Developing and implementing audit plans and strategies to assess the effectiveness of quality management systems
• Providing expert guidance and recommendations to stakeholders on quality assurance best practices and regulatory requirements
• Contributing to the continuous improvement of quality assurance programs and initiatives
• Conducting internal and vendor audits, external audits/Regulatory Authority inspections management, SOP and documentation review 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
• Assist with business development activities, including the preparation of contracted audit cost proposals/contracts, and attend marketing presentation, when appropriate
• Plan and conduct regular internal audits, study/project audits as well as contracted audits (including standalone work), for cause audits, vendor, and sub-contractor audits
• Report the results of the audit and any relevant findings and track them into the ICON systems
• Review audit responses by the auditees, follow up all outstanding replies, and escalate issues to the relevant management for action
• Assist the Q&C management with the development of the internal audit schedule
• Train QA auditors, and provide a standard for auditing to inexperienced or less experienced colleagues
• Lead investigations, root cause analysis (RCA) and resulting CAPA management for ICON Quality Issues
• Ensure ICON’s QMS tracking system is updated with the appropriate information and documentation
• Follow up on CAPA plans to ensure actions are completed on time and the evidences available are adequate
• Determine effectiveness check requirements for responsible CAPA, define the effectiveness check plan, track and complete the effectiveness checks as required, determine the outcome and inform operations and Q&C management accordingly
• Assist Q&C Management with oversight of open CAPAs, trending, and analysis of CAPAs and metrics reporting
• Ensure that any case types including Suspected Scientific Misconduct, Risk Cases, and Potential Serious Breach are tracked and documented as requested

Your profile:

• 5 years of experience in quality assurance in clinical research
• 2 years of experience in either a senior or lead role
• In-depth knowledge of regulatory requirements and guidelines governing clinical trials (ICH-GCP)
• Strong communication skills
• Detail oriented with organizational skills
• Ability to work both independently and as a team
• Bachelors Degree required
• Medical background or BSN preferred
• Ability to travel up to 35% with proximity to an airport

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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.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 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