Quality Issue Lead
Not Disclosed•Full-TimeRemote
location_onFranklin Street, Downtown, Providence, Providence County, Rhode Island, 02902, 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 full 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 will leverage data to assess team performance and drive targeted interventions where needed.
Day in the Life
Your day will involve reviewing submitted quality issues against established criteria to ensure appropriate classification and timely completion. You will document these assessments in the eQMS system and initiate escalations for critical events to keep leadership informed. Once a qualified event is assigned, you will lead the investigation by confirming chronologies, reviewing Standard Operating Procedures (SOPs), and assembling cross-functional teams of subject matter experts to validate details.
Beyond individual 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 for investigation leads. A significant portion of your time will be dedicated to monitoring CAPA (Corrective and Preventive Action) completion, tracking the effectiveness of mitigation actions, and evaluating potential business impacts of identified risks.
Hiring Process
Qualified candidates will be considered for this remote opportunity. Please note that Parexel is an equal opportunity employer and will provide consideration for employment without regard to legally protected status.
Work location
Work model: Remote
Franklin Street, Downtown, Providence, Providence County, Rhode Island, 02902, United States
Providence, Rhode Island
Key Responsibilities
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
A Quality Issue Lead at Parexel is responsible for the following: 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
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 Franklin Street, Downtown, Providence, Providence County, Rhode Island, 02902, United States. This is a remote role.