Senior Director, Development Quality Assurance

Immunome · Bothell, WA

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Role summary

Senior Director of Development Quality Assurance at a clinical-stage oncology company. Responsible for implementing QA strategies across clinical development, ensuring GCP/GLP/GVP compliance, and supporting regulatory readiness across multiple therapeutic programs.

What they're looking for

Deep experience with GCP, GLP, GVP, and global regulatory frameworks (FDA, EMA, ICH)
Proven track record leading quality assurance in clinical drug development
Strong expertise in Quality Management System design and implementation
Experience conducting audits and managing inspection readiness activities
Demonstrated ability to develop compliant processes and drive quality culture

What you'll be doing

Execute DQA objectives and strategies in partnership with VP-level leadership
Provide quality oversight and guidance to Clinical Development, Operations, Pharmacovigilance, and Regulatory teams
Establish and maintain a fit-for-purpose Quality Management System
Conduct risk-based assessments and develop mitigation strategies across development programs
Build organizational quality capabilities through training and cross-functional collaboration

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