GMP Data Specialist


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.


What you will do

Job Description

Let's do this! Let's change the world! In this vital role you will be part of the Global Quality Compliance Team helping to advance the use of digital technology. You will be responsible for capturing, analyzing, and reporting GMP metrics allowing the organization to make data driven decisions. You will act as a subject matter expert for computerized systems, software validation, and data integrity during global compliance audits.


  • Serves as subject matter expert and audit team member for global regulatory requirements in relationship to computerized systems, software validation, and data integrity
  • Generates, maintains, and reports metrics related to the Global Quality Compliance team for ad hoc requests and for regularly scheduled management review meetings
  • Manages, maintains, and improves data analytics tools related to Global Quality Compliance and provides comprehensive training
  • Utilizes statistical techniques to identify compliance trends both internally to Amgen and from external regulatory intelligence
  • Provides support for domestic and international Regulatory Authority Inspections as required
  • Owns and maintains relevant global documents and ensures alignment with the Quality Management System (QMS) architecture
  • Works to resolve deviations and CAPAs assigned to Global Quality Compliance as a team member
  • Supports next generation quality management system project in establishing and testing requirements from the Global Quality Compliance team
  • Supports continual improvement initiatives


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.

Doctorate degree


Master's degree and 3 years of Quality experience


Bachelor's degree and 5 years of Quality experience


Associate's degree and 10 years of Quality experience


High school diploma / GED and 12 years of Quality experience


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.

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.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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