MANAGER, R&D PROCESS QUALITY

As a Manager, R&D Process Quality at Amgen, you will play a crucial role in implementing Amgen's Process Quality strategy to ensure compliance with all applicable regulations and quality requirements. Here's what you can expect in this role: **Role Overview:** You will work with a team dedicated to maintaining Amgen's Research and Development Standards by ensuring clear and effective procedures for all research tasks. Your contribution will support the Quality Management System (QMS) and drive continuous improvement in Amgen's R&D processes. **Key Responsibilities:** - Support Amgen's procedural framework to ensure compliance with laws, regulations, and internal quality standards while upholding ethical and safe treatment of research subjects. - Write clear procedures for diverse research tasks within a cross-functional team, focusing on detail and concise documentation. - Manage change control of business procedures and assess the impact on the QMS, ensuring traceability across document sets. - Collaborate with Business Process Owners to identify and mitigate risks, applying industry-standard processes for procedural documentation. - Utilize process metrics and analytic methods to enable Management Reviews and support QMS continuous improvement. - Collaborate with other quality professionals in R&D for Deviation Management/Corrective and Preventative Actions (CAPA). **Qualifications Required:** - Doctorate degree OR Masters degree and 3 years of quality experience OR Bachelors degree and 5 years of quality experience OR Associates degree and 10 years of quality experience OR High school diploma/GED and 12 years of quality experience. - Direct experience in managing people or leading teams, projects, or programs concurrently with technical experience. **What You Can Expect From Amgen:** Amgen offers a competitive benefits package, including health and welfare plans, financial plans, work/life balance, career development opportunities, and a Total Rewards Plan. The expected annual salary range for this position in the U.S. is provided on the career portal. Join Amgen in making a lasting impact on patients" lives while advancing your career. Apply now at careers.amgen.com. Please note that Amgen does not have a specific application deadline for this position. Apply promptly to be considered for this opportunity to contribute to improving the quality of life for patients worldwide.,