Job description
Description
The Director of Product Quality (Product Quality Steward) serves as a quality expert for the product during clinical development all the way through post-commercialization, and is responsible for making quality-related decisions and serving as a liaison between the project team and other quality functions. This role is the single point of contact for all quality issues associated with the development and commercialization of one or multiple late stage programs. This role serves as the primary Quality point of contact with the Development Partner and participates in all joint discussions, planning and issue resolution between the Quality parties as they relate to TV. This role is a key member of the CMC subteam, providing efficient and effective strategic and quality input into CMC related activities and associated quality decisions. In addition to a later stage program, this position is also responsible for providing Product Quality support for 1-2 early stage clinical programs (TBD).This position reports to the Global Head of Quality for Seattle Genetics and laisses with the wider QA organization to manage the program-related quality activities related to the Quality function and obtain Quality resources to manage the tasks.
Responsibilities
Stewardship