Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Live

What you will do

Let’s do this. Let’s change the world.

The Senior Manager role is a global role and reports to the Director of Quality Operation R&D.

• Contribute to and implementing strategy for R&D process management, modeling and change control

• Implement standards to create, manage and control process maps as key Amgen business assets

• Lead process identification and definition efforts in R&D to ensure end-to-end process mapping and identification of potential failure points and risks

• Contribute process modeling and process management expertise to support R&D business process owners

• Lead targeted process reviews and process improvement efforts

• Identify, establish and implement end to end process hierarchy and process management system

• Identify and define process changes required to address incidents / exceptions and inspection findings

• Lead and assure robust process change control mechanisms for R&D

• Implement and ensure adherence to Business Process Management Standards (BPMS) and BPMS Business Process Management Notation (BPMN)

• Prepare for and contribute to R&D QMS Management Oversight reviews

• Manage change control activities within the BPMS for R&D process models

• Lead cross-functional process improvement activities to address major deficiencies / gaps

• Review process models and oversee acceptance into BPMS

• Opportunity to work remote may be available

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an employee with these qualifications.

Basic Qualifications

Doctorate degree and 2 years of Regulatory & Compliance experience

Or

Master s degree and 6 years of Regulatory & Compliance experience

Or

Bachelor s degree and 8 years of Regulatory & Compliance experience

Or

Associate s degree and 10 years of Regulatory & Compliance experience

Or

High school diploma / GED and 12 years of Regulatory & Compliance experience

Preferred Qualifications

• 8+ years in Quality Management, Process Management, Compliance, or other relevant area of pharmaceutical/biotech industry

• Process management and modelling experience

• Continuous Improvement and change management expertise

• Working knowledge of global regulations impacting R&D activities

• Quality Management System oversight & implementation

• Business Process Management Standards (BPMS) and BPMS Business Process Management Notation (BPMN) Technical expertise

• Continuous Improvement (e.g. Lean, 6 Sigma)

• Global business acumen

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization

• Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act

• Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com