Director, Quality Systems (Fully Remote)

Partner Company; United States; Remote; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Partner Company in the United States seeks a Senior Quality leader to drive an integrated Quality Management System for GxP activities across GMP and GCP functions. You will oversee deviations, CAPA, change control, document control, training, risk management and computerized system validation, and you will build dashboards and metrics to track performance.

This role emphasizes regulatory inspection readiness, including Pre-Approval Inspections, and continuous improvement through data-driven

Aufgaben

• Lead the development and implementation of an integrated QMS covering GxP activities across GMP and GCP functions.
• Oversee deviations, CAPA, change control, document control, training, risk management, and computerized system validation.
• Drive regulatory inspection readiness, including Pre-Approval Inspections, and establish quality metrics, dashboards, and continuous improvement initiatives.

Jobbeschreibung

• Lead the development and implementation of an integrated Quality Management System (QMS) covering GxP activities across GMP and GCP functions.
• Oversee key quality processes including deviations, CAPA, change control, document control, training, risk management, and computerized system validation.
• Drive regulatory inspection readiness, including Pre-Approval Inspections, and establish quality metrics, dashboards, and continuous improvement initiatives.