Quality Issue Lead
Not Disclosed•Full-TimeRemote
location_on1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, 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 within strict timelines and compliance requirements. The Issue Lead oversees the efficiency of GCP investigations, leveraging data to assess team performance and execute necessary interventions.
In this position, you will triage submitted cases to determine if the QE threshold has been met and assess the need for expedited reporting to senior management and regulatory authorities. You will be accountable for managing confirmed Quality Events through the entire investigation lifecycle, including conducting root cause analysis and ensuring all documentation is accurately captured in the eQMS system.
Day-to-Day Impact
Your work will involve reviewing and classifying quality issues against established criteria to ensure appropriate qualification and timely investigation. You will initiate escalations for Critical QEs, ensuring leadership is promptly informed of significant quality events. Once an event is assigned, you will lead the investigation to confirm chronology and details, applying root cause, gap, and due diligence methodologies.
You will collaborate with Subject Matter Experts and study team members to review event details, reviewing relevant SOPs to identify process gaps. Beyond individual case management, you will contribute to process development and improvement, working with PFE Digital to enhance technology and developing guidance documents to support the broader investigation team. You will also monitor CAPA completion, track effectiveness, and evaluate potential business impacts from risk mitigations.
Work location
Work model: Remote
1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, United States
Washington, District of Columbia
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 preferred with 6+ years or equivalent.
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 1100, H Street Northwest, Downtown, Ward 2, Washington, District of Columbia, 20006, United States. This is a remote role.