Director, QA Systems (Contract)
Core
Optimizing Quality systems to ensure adherence to late-stage clinical and commercial multi-regional regulatory requirements and corporate quality objectives.
Role type
Director, QA Systems
Builds
Robust Quality systems and processes covering CMC, Clinical, Regulatory, and IT functions
Domain
Biotechnology / Gene Therapy / Clinical Development
Deliverable
infrastructure
Required skills
Strategic leadership, cross-functional leadership, system optimization, regulatory compliance, process implementation, independent execution
Preferred skills
Ability to work independently, cross-functional collaboration, ethical standards, confidentiality
Technologies
None stated
Responsibilities
Optimize Quality systems for late-stage clinical and commercial regulatory adherence; Lead internal and external CMC functions; Ensure successful integration processes across Eli Lilly functions
Seniority
Director, strategic leadership