Senior Auditor, Quality Assurance-United States-Homebased
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 are currently seeking a Senior Auditor Quality Assurance to join our diverse and dynamic team. As a Senior Auditor Quality Assurance at ICON, you will play a pivotal role in ensuring the quality and compliance of clinical trials, interpreting regulatory requirements, and contributing to the advancement of inNvative treatments and therapies.
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.
Senior Auditor, Quality Assurance Job Description
• Recognize, exemplify and adhere to ICON's values which center on Integrity, Accountability & Delivery, Collaboration, Partnership and Own IT@ICON
• Perform tasks relevant to the assigned Quality & Compliance function which may include but not limited to 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.
•Liaise with clients and operational staff 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, with ICH-GCP and relevant regulations and guidelines.
• Understand key business drivers; uses this understanding to accomplish own work.
• 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.
• If required, support case management processes including potential serious breaches, risk cases and suspected scientific misconduct cases.
• 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.
• *Travel (up to 35%) domestic and/or international, on occasion and this may increase based on business needs.
• Other duties as assigned. 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, 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 as requested.
•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.
• 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.
External Audits /Inspections Management Responsibilities:
• Lead the preparation, and host Sponsor audits & Regulatory Inspections of ICON and of Investigational Sites. This may include but it’s not limited to:
- Supporting ICON and Sponsor operational teams during the audit/inspection
- Liaising with the sponsor as needed
- Reviewing & processing any ICON document requests
- Finalizing and distributing daily summaries
- Attending the audits/inspection on site as needed
- Follow-up activities including provision of outstanding requests
- Lead inspection readiness team activities for projects/programs/assets.
- Support/mentor other Auditors with the tools needed to host independently.
CAPA Management Responsibilities:
• Lead investigations, root cause analysis (RCA) and resulting CAPA management for ICON Quality Issues.
• External audits/inspections findings ensuring responses/CAPA are in line with ICON SOPs and submitted within the require timelines.
• Ensure that the ICON’s QMS/ tracking system is updated with the appropriate information and documentation.
• Follow-up of CAPA plans to ensure actions are completed on time and the evidences available are adequate.
• Perform the assessment of the potential Quality Issues to determine whether they meet the requirements of an ICON Quality Issue , document the outcome and record the Quality Issues as requested.
• 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 with the review of effectiveness check plans and effectiveness check outcomes for more junior QA auditors.
• Assist Q&C Management / Director with oversight of open CAPAs, trending and analysis of CAPAs and metrics reporting. This includes providing summary information/input to Governance reports.
• Support ICON functions and client for regulatory reporting such as regulatory reporting documentation as needed.
• Ensure that any case types including suspected scientific misconduct, risk cases and potential serious breach is tracked and documented as requested.
• Liaise with clients and regulatory authorities as needed
Job Requirements:
- Bachelor's degree in Life Sciences, Pharmacy, or related field; advanced degree preferred.
- Minimum of 5 years of experience in quality assurance within the pharmaceutical, biotechNlogy, biotechnology, or CRO industry, with at least 2 years in a leadership or senior role.
- In-depth kNwledge of regulatory requirements and guidelines governing clinical trials (e.g., ICH-GCP, FDA regulations).
- Strong analytical and problem-solving skills, with the ability to identify and address complex quality issues.
- Excellent communication and interpersonal skills, with the ability to effectively interact with internal and external stakeholders at all levels.
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
