QA GCP experience is required (QA experience on clinical trials)
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.
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
