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Dianthus Therapeutics is seeking a Director of Clinical Quality Assurance to oversee quality compliance for global clinical trials focused on severe autoimmune diseases. This remote role requires extensive experience in GCP and collaboration with cross-functional teams to ensure adherence to regulatory standards and inspection readiness.
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Job Summary
The Director, Clinical Quality Assurance will be responsible for end-to-end quality oversight of global clinical trials to ensure compliance with applicable regulatory requirements and internal standards.
You will provide independent quality oversight of clinical development programs, ensuring that clinical trial conduct, data integrity, and sponsor oversight activities meet expectations of global regulatory authorities.
This is a unique opportunity to join a rapidly growing organization and have a significant impact at Dianthus, with the goal to elevate the care of our patients’ lives.
Matching Summary
Match Score: 75
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Dianthus Therapeutics is seeking a Director of Clinical Quality Assurance to oversee quality compliance for global clinical trials focused on severe autoimmune diseases. This remote role requires extensive experience in GCP and collaboration with cross-functional teams to ensure adherence to regulatory standards and inspection readiness.
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Skills & Requirements
Must-have
GCP compliance oversight
global clinical trials
sponsor oversight frameworks
risk-based audit program
data integrity principles (ALCOA++)
inspection readiness activities
Nice-to-have
culture of quality and compliance
trusted advisor to leadership
continuous improvement
Key Requirements
BS or MS degree in life sciences
12+ years of GxP experience
5+ years in GCP
Experience supporting global clinical trials
Experience supporting submissions and regulatory inspections