Position Summary

The Team Lead, Therapeutic Area Quality is responsible for leading a team of Quality Business Partners that deliver independent quality expert support to key stakeholders. This individual is a member of the Quality Business Partner Therapeutic Area Leadership Team and provides input into the quality strategy of this function. This individual is responsible for ensuring that quality is designed into programs and projects across therapeutic areas and for defining quality activities that ensure submission and inspection readiness.

Job Responsibilities

• Continuously evaluate the strategic approach, drive changes in R&D QuRE processes, and modify the quality strategy and plan to meet changing organizational, regulatory, and industry needs.
• Identify and drive continuous quality improvements resulting from risk assessments, audits, inspections, trends/metrics, and root cause analysis.
• Provide input into the global audit pla...