Product Quality Director, Puerto Rico

The successful candidate will become a Global Product Quality Leader for two of Amgen’s commercial products. The individual will provide technical expertise and leadership to a Commercial Product Quality Team to develop, implement, and manage strategy for Quality to meet project goals for an Amgen commercial product. In addition, the GPQL will be responsible for overall strategy and interactions between each Amgen site responsible for the manufacturing or distribution of the product. As a product expert in Quality, the GPQL has responsibility for working with site PQL’s, PD, QA, Regulatory etc. on the resolution of issues associated with analytical methods, specifications, data trending, reference standards, scale-up, process support, validation, investigations, change control, regulatory submissions and regulatory guidance interpretation, and inspections. In addition to these responsibilities, the candidate will be expected to play a role in establishing quality processes and systems to support protein product development.

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