Quality Issue Lead - FSP

Parexel•Southport, NC

1d•Remote

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel FSP is looking for Issue Leads in the US or Canada! Job Summary 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 we conduct 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

BS – 7+ years or equivalent
MS/MBA – 6+ years or equivalent
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.

Responsibilities

Review and classification of submitted quality issues to ascertain if the QE threshold has been met.
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.
Complete the necessary documentation in the eQMS system regarding the assessment of the submitted events.
Initiate appropriate escalation of Critical QEs when necessary, ensuring that management is promptly and appropriately informed of quality events.
Assess critical issues and identify these items as appropriate for escalation to leadership via the Notification to Management process.
Initiate the investigation of the event to confirm the chronology and details of the issue.
Apply a root cause analysis, gap analysis, and / or due diligence investigation to the case.
Review relevant SOPs and supporting documents to understand what should have happened per our documented process and identifying what did not happen per the process.
Review 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.
Contribute to process development and improvement for case management including contributing to the development of technology (in collaboration with PFE Digital) to enable the process.
Develop and implement guidance documents and training to assist the investigation leads in completing cases to expectations.
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.
Track and ensure implementation of risk mitigations and evaluate potential impacts to business.