Director of Quality Operations

5 days ago


King of Prussia, Pennsylvania, United States CSL Behring Full time

About the Role

The Director of Quality Operations will lead a dedicated team responsible for quality oversight in the entire R&D organization. This role ensures that quality policies and processes are appropriate for the phase of R&D development and comply with corresponding regulations.

This position is responsible for ensuring alignment to an enterprise approach for application of the QMS within R&D, covering the entire R&D GxP spectrum. The role provides quality oversight for toxicology studies, clinical development, clinical supply manufacture, and packaging, as well as medical device and combination products regulations.

The Director will lead and coordinate all regulatory GxP inspections for the R&D teams and across development programs, including new commercial product introductions. This role also participates in key R&D Governance bodies, including the Global Safety Committee.



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