Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Specialist Quality System

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will work on project management for Amgen globally relating to the Pharmacopeia Affairs Desk and related external engagement activities.

Key Responsibilities

• Project Managing Pharmacopeia affairs globally for Amgen.
• Gaining knowledge internally and externally about early signals, current hot topics and evolving issues impacting Amgen Operations globally and in region/countries
• Setting up, manage and improve related data bases in External Affairs
• Carrying out assessments, analysis of data sources and communication back into the organization through established channels.
• Working internally to seek alignment, support and scientific knowledge on related developments in external landscape.
• Representing Amgen’s approved positions in appropriate external organizations (e.g., PhRMA and/or EFPIA and/or BIO and/or PDA) by shaping the external environment including related policy initiatives.
• Collaborating closely with regulators facilitated by industry associations, as assigned.
• Taking on additional projects with focus on accountabilities or development opportunities, as applicable.
• Providing support and act as backup to one another position in External Affairs
• Traveling in country and internationally as required to fulfill the company needs (approx. up to 15%).

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a Specialist with these qualifications.

Basic Qualifications:

Doctorate degree

OR

Master’s degree and 3 years of Quality experience

Or

Bachelor’s degree and 5 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

Preferred Qualifications

• Experience in a laboratory e.g., Quality Control, Development, highly appreciated.
• Understanding of global Regulatory and Quality requirements focused on GMP/GDP, QMS, Supply chain and potentially also CMC
• Ability to interpret, synthesize, and communicate information, not simply summarize
• Creative and independent problem solver
• Ability to build relationships and use influence effectively in a variety of settings, both within the company and with external organizations including public officials, trade associations and other relevant parties.
• Possesses unquestionable integrity and a sense of confidence, balanced with humility
• Experience in leading external organization topic teams such as PhRMA, PDA, etc. preferred
• Recognized as a speaker at internal meetings / conferences on current Quality / CMC topics.
• Excellent English communication skills both written and oral, and presentation skills
• Appropriate cultural awareness and ability to work effectively with those from other countries, particularly the emerging market areas in which Amgen is interested.
• Ability to develop and maintain data bases

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey
• A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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