Quality Issue Lead
Not Disclosed•Full-TimeRemote
location_on702, West Camelback Road, Alhambra, Phoenix, Maricopa County, Arizona, 85013, United States
About the Role
Parexel FSP is seeking an Issue Lead to drive Quality Event (QE) case management across the US or Canada. This role is critical for ensuring that investigations are conducted thoroughly, adhering to strict timelines and compliance requirements. The Issue Lead serves as the guardian of the investigation process, leveraging data to assess team performance and intervene where necessary to maintain quality standards.
In this position, you will triage submitted cases to determine if they meet the QE threshold and assess the need for expedited reporting to senior management or regulatory authorities. Once a Quality Event is confirmed, you will be accountable for managing the entire investigation lifecycle, including conducting root cause analysis and ensuring all documentation is accurately captured in the eQMS system.
Your day-to-day involves reviewing submitted issues against established criteria to ensure appropriate classification and timely completion. You will initiate escalations for Critical QEs, ensuring leadership is promptly informed. For qualified events, you will lead investigations to confirm chronology and details, applying root cause, gap analysis, and due diligence methodologies. This includes reviewing Standard Operating Procedures (SOPs), assembling cross-functional teams with subject matter experts, and verifying event details.
Beyond case management, you will contribute to process development and improvement, collaborating with PFE Digital on technology enhancements. You will also help develop guidance documents and training materials to support investigation leads. A key part of your responsibility is monitoring the completion and effectiveness of CAPA (Corrective and Preventive Action) plans for quality events, inspections, and audits, while tracking risk mitigations and evaluating their impact on the business.
Work location
Work model: Remote
702, West Camelback Road, Alhambra, Phoenix, Maricopa County, Arizona, 85013, United States
Phoenix, Arizona
Key Responsibilities
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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: 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 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 702, West Camelback Road, Alhambra, Phoenix, Maricopa County, Arizona, 85013, United States. This is a remote role.