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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.

Senior Auditor – Clinical Trials / GCP (UK - remote)

LIVE

What you will do

In this vital role within R&D Auditing you will be planning and participating in global audits of Amgen’s clinical trials and pharmacovigilance activities. You may also support regulatory inspections of clinical sites and Amgen facilities. The key responsibilities include:

• Plan, conduct and report routine and directed GCP  and/or PV compliance audits internationally.
• Serve as a lead auditor for complex GCP and /or PV audit types
• Identify and communicate compliance risks to QA and R&D management
• Host and/or play a role in regulatory authority inspections
• Contribute to or lead QA process improvement initiatives
• Author and contribute to the development of QA cross functional controlled documents

Currently all auditing being conducted remotely, pending easing of travel restrictions the role can entail up to 30% travel to international destinations

Be part of our team

You would be joining Amgen’s R&D  Audit Team of expert,  professional and widely experienced individuals working with a global remit across Amgen’s portfolio in all stages of development and post marketing. The R&D audit team is part of Amgen's Global Compliance Team.

WIN

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced  professional, are these qualifications and skills:

• Bachelor’s degree in a scientific discipline, medical sciences or pharmacy qualification
• Extensive international auditing conduct experience in GCP and/or Pharmacovigilance or as regulatory authority inspector
• Experience of data mining, manipulation and data analytics would be advantageous
• Excellent written and verbal communication skills

Preferred Qualifications:

• Experience supporting regulatory authority inspections
• Participation in process improvement initiatives.
   

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
• This role is based in UK and can be at either be based at our offices (Cambridge or Uxbridge with flexibility to work from home) or remote based within the UK.

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

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.