Quality Issue Lead
Not Disclosed•Full-TimeRemote
location_on1124, Bratton Street, Jackson, Hinds County, Mississippi, 39203, United States
About the Role
Parexel FSP is seeking Issue Leads in the US or Canada to drive the integrity and efficiency of our Quality Event (QE) case management. In this role, you will serve as a critical guardian of compliance, ensuring that all investigations are conducted thoroughly, within strict timelines, and in adherence to Good Clinical Practice (GCP) requirements.
You will be the central point of contact for triaging submitted cases to determine if they meet the QE threshold. Your expertise will be essential in assessing whether issues require expedited reporting to senior management or regulatory authorities. Once a case is confirmed, you will manage the entire investigation lifecycle, from initial chronology review to deep-dive root cause analysis and gap analysis. This involves collaborating with Subject Matter Experts and study teams to assemble the necessary stakeholders and ensure a comprehensive understanding of the event.
Beyond individual case management, you will play a key role in process improvement. You will contribute to the development of technology solutions and guidance documents that help the broader team execute investigations to expectation. Your work will directly impact risk mitigation by tracking the completion and effectiveness of CAPA plans, ensuring that remediation actions for quality events, inspections, and audits are working as intended.
Work location
Work model: Remote
1124, Bratton Street, Jackson, Hinds County, Mississippi, 39203, United States
Jackson, Mississippi
Key Responsibilities
- check_circleManage confirmed Quality Event cases through the investigation process including root cause analysis
- check_circleInitiate escalation of Critical Quality Events to senior management and regulatory authorities
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
A Quality Issue Lead at Parexel is responsible for the following: Manage confirmed Quality Event cases through the investigation process including root cause analysis; Initiate escalation of Critical Quality Events to senior management and regulatory authorities; Conduct gap analysis and due diligence investigations by reviewing SOPs and supporting documents; and Develop and implement guidance documents and training to assist investigation leads.
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, SOPs, and regulations.
Where is the Quality Issue Lead role at Parexel located?expand_more
Quality Issue Lead at Parexel is based in 1124, Bratton Street, Jackson, Hinds County, Mississippi, 39203, United States. This is a remote role.