Senior Director, Development Quality Assurance at Immunome, Inc. · Bothell, WA · Joined
II
Senior Director, Development Quality Assurance
Immunome, Inc. · Bothell, WA · Just now · 0 applicants
NewOn-siteFull-timeManager
Pay
$260k–$294kListed
Workplace
On-site
Job type
Full-time
Level
Manager
Team: Development Quality Assurance · Source: jobright · Posted by joined-scrapper
About the role
Immunome is seeking a Senior Director of Development Quality Assurance to lead quality strategy, ensure GxP and regulatory compliance, and drive continuous improvement across clinical development. This role partners with Development functions to strengthen the Quality Management System and maintain inspection readiness.
What you’ll do
Implement quality strategies supporting clinical development
Ensure compliance with global GxP and regulatory requirements
Strengthen the Quality Management System
Manage quality risks and inspection readiness
Drive continuous improvement across quality processes
Partner across Development functions to improve quality outcomes
What you’ll need
Bachelor's or Master's degree in Chemistry, Biochemistry, Clinical Pharmacology, Life Sciences, or related field
Minimum 15 years of experience in biotechnology, pharmaceutical, or life sciences in GxP-regulated environments
Minimum 5 years of leadership experience managing quality professionals
Demonstrated experience building, implementing, or improving Quality Management Systems
Deep knowledge of GCP, GLP, GVP, FDA, EMA, ICH guidelines, and global regulatory requirements
Experience supporting Health Authority inspections, CAPA management, and risk management activities
Original job description
Immunome, Inc. is hiring a Senior Director of Development Quality Assurance to implement quality strategies supporting clinical development and ensure compliance with global GxP and regulatory requirements. The role partners across Development functions to strengthen the Quality Management System, manage quality risks and inspection readiness, and drive…