Quality ICM Issue Lead

ICON plc • Blue Bell, SD

9d • Remote

About The Position

The Issue Lead will be responsible for driving QE case management, ensuring that investigations are conducted thoroughly within timelines and compliance requirements, overseeing the efficiency of the process of GCP investigations, and leveraging data to assess the efficiency / performance of the appropriate teams to perform interventions as needed. The Issue Lead will also triage submitted cases to ascertain if the Quality Event (QE) threshold has been met and assess cases to determine if they need expedited reporting to senior management and/regulatory authorities and be accountable for managing confirmed Quality Event (QE) case through the investigation process including root cause analysis.

Requirements

• 7+ years’ experience or equivalent with BS or 6+ years’ experience or equivalent with MBA/MS
• Minimum of 5 years of pharmaceutical experience with solid experience in data management, operational aspects, GCP Quality, GxP Quality, and/or regulatory
• Regulatory inspection experience
• Process and system management experience
• Detailed knowledge of clinical trial processes and relationships required
• Knowledge of GCP requirements and applicable SOPs and regulations
• Project management, administrative, and technical capabilities are required, as well as effective verbal and communication skills.
• Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.

Responsibilities

• Review and classification of submitted quality issues to ascertain if the QE threshold has been met and ensuring that each submitted issue is reviewed based on the established criteria, is categorized appropriately, and completed within the required time frame to ensure that events are appropriately qualified enabling expedited investigation where necessary.
• Completing the necessary documentation in the eQMS system regarding the assessment of the submitted events.
• Initiating appropriate escalation of Critical QEs when necessary, ensuring that management is promptly and appropriately informed of quality events.
• Assessing critical issues and identify these items as appropriate for escalation to leadership via the Notification to Management process.
• Initiating the investigation of the event to confirm the chronology and details of the issue.
• Applying a root cause analysis, gap analysis, and / or due diligence investigation to the case.
• Reviewing relevant SOPs and supporting documents to understand what should have happened per our documented process and identifying what did not happen per the process.
• Reviewing relevant documentation re: the event and assembling the QE team with appropriate stakeholders (SME's, study team members, etc.) to review and confirm the details of the event.
• Contributing to process development and improvement for case management including contributing to the development of technology (in collaboration with PFE Digital) to enable the process.
• Developing and implementing guidance documents and training to assist the investigation leads in completing cases to expectations.
• Ongoing monitoring of CAPA completion and tracking of effectiveness for implemented mitigation actions to ensure they are working as expected—for quality events, inspections and audits.
• Ensuring implementation of QE / audit / inspection CAPAs and remediation plans.
• Tracking effectiveness checks and reporting on trends.
• Tracking and ensuring implementation of risk mitigations and evaluating potential impacts to business.

Benefits

• 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior