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Regulatory Compliance Specialist

1 month ago


Bothell, Washington, United States Immunome Full time
Job Overview

The Senior Director/Director of Quality Operations is responsible for developing and leading quality programs for both commercial and clinical manufacturing operations, ensuring compliance with global regulatory standards.

This role interacts with executive leadership to communicate quality initiatives, issues, and resource requirements, ensuring alignment with corporate compliance goals.

  • Responsibilities
  • Develop and implement metrics to monitor and report on the performance of Operations, identifying areas for improvement and ensuring corrective actions are implemented.
  • Provide strategic direction and hands-on leadership for operations teams, ensuring alignment with business goals and regulatory demands.
  • Mentor, coach, and develop a high-performing quality team to support the growth of the organization.