Quality Issue Lead
Not Disclosed•Full-TimeRemote
location_onVermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, 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 that investigations are conducted thoroughly, efficiently, and in strict compliance with Good Clinical Practice (GCP) requirements.
As an Issue Lead, you will serve as the gatekeeper for quality events, triaging submitted cases to determine if they meet the QE threshold. You will be accountable for managing confirmed QEs from initial assessment through the investigation process, including conducting root cause analysis and determining if expedited reporting to senior management or regulatory authorities is necessary. Your work ensures that data is leveraged to assess team performance and that interventions are made where needed to maintain quality standards.
Day in the Life
Your day will involve reviewing submitted quality issues against established criteria to ensure appropriate classification and timely completion within the eQMS system. You will initiate investigations to confirm the chronology of events, applying root cause, gap, and due diligence methodologies to understand process deviations.
Collaboration is key; you will assemble QE teams with subject matter experts and study members to review event details and verify documentation. Beyond individual case management, you will contribute to process development and improvement, working with PFE Digital on technology enhancements and developing guidance documents to assist investigation leads. You will also monitor the completion and effectiveness of CAPA plans and track risk mitigations to evaluate potential business impacts.
Hiring Process
Qualified candidates will be considered for employment without regard to legally protected status. Please note that this position is listed as remote (#LI-REMOTE).
Equal Opportunity
Parexel is an equal opportunity employer. We consider qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Work location
Work model: Remote
Vermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States
Montpelier, Vermont
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
- check_circleDevelop and manage CAPA plans to track effectiveness of mitigation actions for audits and inspections
- check_circleTrack risk mitigations and evaluate potential impacts to business operations
- check_circleReview and classify submitted quality issues to determine if Quality Event thresholds are met
- check_circleContribute to process development and create guidance documents for investigation leads
Requirements
- verifiedBS degree with 7+ years experience or MS/MBA with 6+ years experience
- verifiedMinimum 5 years pharmaceutical experience
- verifiedRegulatory inspection experience
- verifiedProcess and system management experience
- verifiedDetailed knowledge of clinical trial processes
- verifiedKnowledge of GCP requirements and applicable SOPs and regulations
- verifiedProject management, administrative, and technical capabilities
- verifiedStrong background in continuous improvement methodology (i.e., Lean Six Sigma) preferred
Nice to Have
Strong background in continuous improvement methodology (i.e., Lean Six Sigma)
Similar Job Opportunities
Skills, education and keywords
Skills: GCP, GXP, Root Cause Analysis, Gap Analysis, Due Diligence, Sop, Capa, Lean Six Sigma.
Education: Master's or MBA preferred with 6+ years 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 risk mitigations and evaluate potential impacts to business operations.
What are the requirements for this Quality Issue Lead role?expand_more
To qualify for the Quality Issue Lead 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 role at Parexel located?expand_more
Quality Issue Lead at Parexel is based in Vermont State Office Building, 118-120;120, State Street, Montpelier, Washington County, Vermont, 05602, United States. This is a remote role.
Is this Quality Issue Lead job remote, hybrid, or on-site?expand_more
Parexel has listed this Quality Issue Lead role as remote.
How much experience is required for this Quality Issue Lead role?expand_more
Quality Issue Lead at Parexel typically requires 5+ years of relevant experience at the senior level.
What skills do you need for the Quality Issue Lead role at Parexel?expand_more
Key skills for Quality Issue Lead at Parexel include GCP; GXP; Root Cause Analysis; Gap Analysis; Due Diligence; Sop; Capa; and Lean Six Sigma.
What education is required for Quality Issue Lead at Parexel?expand_more
Educational requirements for this role: Master's or MBA preferred with 6+ years experience.
What category does the Quality Issue Lead role belong to?expand_more
Quality Issue Lead at Parexel is part of the healthcare & nursing job category on Recrutus.