Senior Director, Development Quality Assurance
Immunome
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.
Responsibilities
- 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
Requirements
- 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
Vacancy posted 9 days ago
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