Career Category

Job Description

Job Title

Specialist - GxP Governance Deviation Management

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 - GxP Governance Deviation Management

Live

What you will do

[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.

Job Summary

This global technical role, reporting to the Principal - GxP Systems Governance & Assurance will be responsible for managing GxP Systems deviations for all IS systems and IS GxP processes and acting as the main link between the GxP Quality organization and IS management.

To be successful, you will require strong collaboration with IS Management, GxP Systems Quality and GxP Systems Audit, IS service and system owners, and other Amgen internal partners to maintain and improve Amgen’s IS compliance landscape. Travel requirements may vary, depending on specific projects.

Key responsibilities

You will bring forth out of the box thinking, an agile mindset and substantial enterprise process ownership experience to empower application and product owners to build and maintain IT solutions with compliance, by design. You will become an advisor and an authority on GxP Systems deviation management for the IS organization.

You will perform the following activities and any additional tasks required to support and continuously improve Amgen's compliance posture, to effectively reduce risks and satisfy the security objectives of the organization.

Win

What we expect of you

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

• Serve as the GxP deviation SME for IS users and be accountable for ensuring GxP compliance within IS by timely and effectively running deviations.
• Ensure operational alignment with GxP Systems Quality team on quality requirements and support IS management in all phases of the quality deviation management process.
• Be part of the global GxP deviation network, representing the IS organization.
• Lead GxP systems deviations and deliver trend deviations for IS.
• Contribute to the strategic development of the GxP Systems compliance by supporting the development and maintenance of a governance framework to measure, supervise and manage GxP systems compliance.
• Measure and monitor GxP systems compliance, from a GxP deviations perspective.
• Assist in the review of GxP deviation process updates and documentation (e.g. SOPs, PLANs, TPLs) as changes are periodically introduced, providing IS input

Basic Qualifications

• Master’s degree and 5 years of Information Systems experience
• OR
• Bachelor’s degree and 5 years of Information Systems

Win

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 maximize 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.

careers.amgen.com

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 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 accommodation.