Let’s do this. Let’s change the world. In this vital role you will be the champion for a product team as the Product Quality Leader (referred to as PQL), providing technical expertise, strategic and project leadership to the Product Quality (PQ) organization. The PQL has responsibility for working with PQ staff and executive leadership, International Quality, Quality Control, Contract Manufacturing Quality, Regulatory, Process Development, Quality Assurance, and other functional areas on the resolution of issues associated with process/manufacturing, in process controls, analytical methods, specifications, comparability, stability, reference standards, importation testing, investigations, change control, regulatory submissions and inspections. The PQL has responsibility for inspiring change to implement operationally efficient processes and corporate alignment across international sites. As a leader in Product Quality, the successful candidate is expected to have experience, knowledge and understanding of large molecule development and commercial lifecycle maintenance, product stability programs, regulatory filings, risk assessment, and Amgen Quality Management Systems.
Amgen offers the opportunity to be at the interface between research, global development, and manufacturing to ensure that our molecules become medicines. Many of the technologies we’re employing are not only new to Amgen but are new to the industry as a whole. Help us to pave new roads for helping patients.
This role is directly responsible for the product quality and related activities (e.g., comparability, specifications, stability, annual product review) in support of the Product Development Team (PDT). The PQL provides scientific oversight for the product quality of pivotal and/or commercial product(s) including timely product data review, ownership of GMP documents and regulatory filing sections, execution of transactions in relevant GMP system (EDMQ, change control, etc), and support for regulatory audits and responses to questions. The individual is directly responsible to lead a Product Quality Team (PQT), including oversight of the product stability programs, and providing indirect staff management and guidance to members of the PQT.