Senior Quality Specialist, Client Quality Management
Core
Implement and maintain quality systems and training for assigned client projects to ensure compliance with global regulations, legislation, and client requirements.
Role type
Senior Quality Specialist (Pharmacovigilance)
Builds
Quality management plans, training matrices, and compliant project operations for life sciences clients
Domain
Life Sciences / Pharmacovigilance / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> client delivery
Required skills
Pharmacovigilance experience, GxP environment experience, Quality system implementation, Training management, Regulatory intelligence analysis, SOP development, CAPA management, Audit coordination, Risk assessment, Deviation reporting
Preferred skills
None stated
Technologies
PACS systems
Responsibilities
Create and maintain project-specific quality management plans and training matrices; Review regulatory intelligence reports and assess impact on projects; Ensure project procedures align with global Pharmacovigilance regulations and guidelines; Review and approve access requests to controlled systems; Monitor project metrics and KPIs; Perform final quality reviews on processed cases; Act as main point of contact for audit activities; Manage deviations and CAPAs; Ensure inspection readiness.
Seniority
Senior, hands-on IC
