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 Quality Management System is the foundation of all that we manufacture, test, and store at Amgen to support our biggest mission, to serve patients. This highly visible position will lead efforts to assure our quality management system (QMS) is suitable, adequate, and effective. This position will participate in the transformation of the QMS towards our “One QMS” ambition: a single, central, simple quality system that works for all product types and all lifecycle phases. This position sits in Corporate Quality Systems, collaborate with executive leadership, and is involved with the QMS strategy.

This position is eligible for remote work.

Responsibilities:

▪Owns the Quality Manual, Management Review, and Standards processes. Also owns the Process Overview and Multisite SOP’s for these . Assures alignment with document hierarchy and document templates

▪Coordinates and compiles the QLT and Corporate level management review to assure senior leadership can maintain a suitable and effective QMS.

Assure senior and executive management roles expectations are cear, assigned, and documented

▪Owns and acts upon performance metrics and process issues, implementing actions to drive continuous improvement and raising to management for support if needed

▪Leads and coordinates critical activities to ensure compliance throughout the network: gap assessments, commitments, response to audit & inspection findings and deviations

▪Leads continuous process improvements and partners with network SME’s on key initiatives

▪Supports regulatory inspections and audits

▪Maintains assigned global quality process in compliance with all applicable global regulations and global Amgen specific requirements

▪Monitors GMP Surveillance and takes vital actions to align process to applicable new or revised regulatory requirements

▪Leads network and cascades requirements and QMS architecture down to all applicable sites and functions. Advises sites early of changes to ensure consistency

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The vital attribute professional we seek will have these qualifications.

Basic Qualifications

Doctorate degree and 2 years of Quality experience

OR

Master’s degree and 6 years of Quality experience

OR

Bachelor’s degree and 8 years of Quality experience

OR

Associate’s degree and 10 years of Quality experience

Or

High school diploma / GED and 12 years of Quality experience

And

2 years of managing a global network team and broad Pharmaceutical, Medical Device, or Combination Product experience.

Preferred Qualifications

• 5+ years managing Quality professionals s

• Leadership experience in a pharmaceutical/combination products/device at a corporate level

• Experience leading medium or large projects at a global level

• Experienced in Agile Quality Systems and Continuous Improvement Tools

• 4+ years managing Quality professionals or project manager

• Ability to build, maintain, prioritize and present QMS improvement strategy

• Autonomous problem solver, willing to take informed and appropriate risks

• Broad and deep knowledge of the Amgen Quality Management System (QMS)

• Understand global, regional and local commercial business (speak commercial)

• Understanding of Amgen’s strategy and organizations

• Innovation, Agile mentality with aptitude for developing ideas into measurable objectives

• Other language skills

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.

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Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.