Quality Issue Lead - FSP
Not Disclosed•Full-TimeRemote
location_on1463, West Indianhead Drive, Tallahassee, Leon County, Florida, 32301, United States
About the Role
Parexel FSP is seeking Issue Leads in the US or Canada to drive Quality Event (QE) case management. This role is critical for ensuring investigations are conducted thoroughly, efficiently, and in full compliance with Good Clinical Practice (GCP) requirements.
As an Issue Lead, you will serve as the primary owner of the investigation lifecycle. Your day-to-day involves triaging submitted cases to determine if they meet the QE threshold, assessing the need for expedited reporting to senior management or regulatory authorities, and managing confirmed events from initial assessment through root cause analysis. You will leverage data to evaluate team performance and implement necessary interventions.
Beyond individual case management, you will contribute to process development and improvement. This includes collaborating with PFE Digital on technology enhancements, developing guidance documents, and creating training materials to support investigation leads. You will also monitor the completion and effectiveness of Corrective and Preventive Actions (CAPA) and track risk mitigations to evaluate their impact on the business.
Work location
Work model: Remote
1463, West Indianhead Drive, Tallahassee, Leon County, Florida, 32301, United States
Tallahassee, Florida
Key Responsibilities
- check_circleConduct thorough GCP investigations including root cause and gap analysis for quality events
- check_circleInitiate escalation of critical quality events to senior management and regulatory authorities
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Similar Job Opportunities
Skills, education and keywords
Skills: GCP, GXP, Root Cause Analysis, Gap Analysis, Due Diligence, Sop, Capa, Lean Six Sigma.
Education: MS or MBA preferred with 6+ years or equivalent.
Frequently asked questions about Quality Issue Lead - FSP at Parexel
What does a Quality Issue Lead - FSP at Parexel do?expand_more
A Quality Issue Lead - FSP at Parexel is responsible for the following: Conduct thorough GCP investigations including root cause and gap analysis for quality events; Initiate escalation of critical quality events to senior management and regulatory authorities; Develop and manage CAPA plans to track effectiveness of mitigation actions for audits and inspections; and Track and ensure implementation of risk mitigations while evaluating potential business impacts.
What are the requirements for this Quality Issue Lead - FSP role?expand_more
To qualify for the Quality Issue Lead - FSP at Parexel position, applicants should have: BS degree with 7+ years experience or MS/MBA with 6+ years experience; Minimum 5 years pharmaceutical experience; Regulatory inspection experience; Process and system management experience; Detailed knowledge of clinical trial processes; and Knowledge of GCP requirements and applicable SOPs and regulations.
Where is the Quality Issue Lead - FSP role at Parexel located?expand_more
Quality Issue Lead - FSP at Parexel is based in 1463, West Indianhead Drive, Tallahassee, Leon County, Florida, 32301, United States. This is a remote role.