Compliance Specialist in the Audits & Inspections Knowledge Center
Core
Executes quality and compliance processes across the organization, tracking metrics, maintaining documentation, and supporting Audits & Inspections teams.
Role type
Compliance Specialist (Quality & Regulatory)
Builds
Compliance metrics, dashboards, scorecards, and quality agreements for Audits and Inspections teams.
Domain
Life Sciences / Clinical Trials / Regulatory Compliance
Deliverable
dashboards & analysis
Required skills
ICH GCP knowledge, clinical trial process knowledge, data analysis, report generation, process improvement, Veeva data management, change management, quality agreement negotiation.
Preferred skills
None stated.
Technologies
Veeva
Responsibilities
Research issues and track metrics for quality and compliance; Administer quality and compliance processes; Generate compliance metrics and trending reports; Develop and validate dashboards and scorecards; Manage CDA process and changes to applications; Support negotiation of Quality Agreements; Review Planned Deviations.
Seniority
Mid-level (2+ years experience)