Quality Issue Lead
Not Disclosed•Full-TimeRemote
location_onHelena Solid Waste Department, Centennial Trail, Helena, Lewis and Clark County, Montana, 59625, 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. The Issue Lead serves as the central point for assessing submitted cases, determining if they meet the QE threshold, and managing the investigation lifecycle from initial triage through root cause analysis and CAPA tracking.
In this position, you will leverage data to assess team performance and intervene where necessary. Your day-to-day involves reviewing quality issues against established criteria, categorizing them appropriately, and ensuring all documentation is accurately captured in the eQMS system. You will be responsible for initiating escalations for critical events to senior management and regulatory authorities, ensuring timely and appropriate communication. Once a qualified event is assigned, you will lead the investigation to confirm chronology, apply root cause and gap analysis methodologies, and collaborate with subject matter experts and study teams to validate event details.
Beyond case management, this role contributes to process development and improvement. You will work with PFE Digital to develop technology solutions that streamline case management and collaborate with Senior Issue Leads to create guidance documents and training materials. You will also monitor the completion and effectiveness of CAPA plans for quality events, inspections, and audits, while tracking risk mitigations and evaluating their potential impact on the business.
Work location
Work model: Remote
Helena Solid Waste Department, Centennial Trail, Helena, Lewis and Clark County, Montana, 59625, United States
Helena, Montana
Key Responsibilities
- check_circleConduct thorough GCP investigations including root cause and gap analysis for quality events
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 with 6+ years or equivalent experience.
Frequently asked questions about Quality Issue Lead at Parexel
What does a Quality Issue Lead at Parexel do?expand_more
In this Quality Issue Lead at Parexel role, you will 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 role?expand_more
Parexel is looking for candidates who meet the following requirements: 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 role at Parexel located?expand_more
Quality Issue Lead at Parexel is based in Helena Solid Waste Department, Centennial Trail, Helena, Lewis and Clark County, Montana, 59625, United States. This is a remote role.