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 by which the Sponsor conducts 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.

Quality Event Assessment and Investigation:

This individual will be accountable for the review and classification of submitted quality issues to ascertain if the QE threshold has been met. He or she will ensure 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. This individual will also be responsible for completing the necessary documentation in the QMS system regarding the assessment of the submitted events.

Notification to Management:

This individual will be responsible for initiating appropriate escalation of Critical QEs when necessary, ensuring that management is promptly and appropriately informed of quality events. The Issue Lead will be required to assess critical issues and identify these items as appropriate for escalation to leadership via the Notification to Management process.

Root Cause Analysis / Gap Analysis / Due Diligence:

Once assigned a qualified event, the Issue Lead will initiate the investigation of the event to confirm the chronology and details of the issue. This individual will also be required to apply a root cause analysis, gap analysis, and / or due diligence investigation to the case. The individual will be trained in the application of an appropriate methodology and will apply it as part of the management of the case. Investigation will include 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. In addition, the investigation will include review of 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

Process Analysis and Improvement:

This individual will be responsible for contributing to process development and improvement for case management including contributing to the development of technology to enable the process. In addition, the individual, along with Senior Issue Lead peers, will develop and implement guidance documents and training to assist the investigation leads in completing cases to expectations.

CAPA Plan Development and Management:

This individual will hold accountability for 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

• Ensure implementation of QE / audit / inspection CAPAs and remediation plans
• Track effectiveness checks and report on trends

Risk Mitigation Tracking

Track and ensure implementation of risk mitigations and evaluate potential impacts to business.

Education:

BS – 7+ years or equivalent

MS/MBA – 6+ years or equivalent

Experience:

• 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
• Strong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred.