Quality Issue Lead
Not Disclosed•Full-TimeRemote
location_on948, Spencer Street, Makiki Kai, Honolulu, Honolulu County, Hawaii, 96822, 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, adhering to strict timelines and compliance requirements. The Issue Lead serves as a key guardian of data integrity and process efficiency, leveraging data to assess team performance and execute necessary interventions.
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. 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.
Your day-to-day will involve reviewing submitted quality issues against established criteria, initiating appropriate escalations for critical events, and leading investigations to confirm chronology and details. You will apply root cause, gap, and due diligence methodologies, reviewing relevant SOPs and assembling cross-functional teams to validate event details. Additionally, you will contribute to process development, collaborate with PFE Digital on technology enablement, and help develop guidance documents and training for investigation leads.
Hiring Process
Qualified candidates will be considered for employment without regard to legally protected status. Parexel is an equal opportunity employer committed to diversity and inclusion.
Work location
Work model: Remote
948, Spencer Street, Makiki Kai, Honolulu, Honolulu County, Hawaii, 96822, United States
Honolulu, Hawaii
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 experience.
Frequently asked questions about Quality Issue Lead at Parexel
What does a Quality Issue Lead at Parexel do?expand_more
Day-to-day, the Quality Issue Lead at Parexel 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 948, Spencer Street, Makiki Kai, Honolulu, Honolulu County, Hawaii, 96822, United States. This is a remote role.