GxP Learning Process, Governance, & Metrics, Sr Manager

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

GxP Learning Process, Governance, & Metrics, Sr Manager

What you will do

Let’s do this. Let’s change the world. In this vital role you will drive the Learning process optimization and improvement across Global Quality and GxP in partnership with critical stakeholders across the matrix. This will include serving on the GxP Learning Community of Practice (CoP) and driving change across the Learning Ecosystem (Operations and R&D). The role will drive achievement and improvement of the GxP Learning processes through continuous improvement and metrics, driving transformation of the learning landscape.

• Partner with cross functional leadership in developing and rolling out a culture of learning performance.
• Maintain global processes, procedures, and training materials in compliance with Global GxP requirements, Amgen Global Quality Standards, and Amgen’s Quality Management System (QMS) principles.
• Participate in Community of Practice (CoP), driving continuous improvement, change management, and overall learning governance.
• Identify and implement solutions in partnership with the Learning CoP across the Learning Ecosystem to eliminate waste and simplify.
• Drive quality growth mindset to establish a center of excellence for Quality capability building, defining standards, deployment model, in collaboration with Quality Leadership and key learning leads.
• Develop capability / competency-based processes to reduce and/or replace read & understood.
• Participate in benchmarking initiatives with peers externally to stay abreast of changes in regulations that affect impacted processes
• Define process monitoring methods, specific to metrics and analysis across the learning ecosystem for Quality, Operations, and R&D functional areas.
• Support site and functions during regulatory …