R&D Quality GCP Auditor

Amgen; City Of London; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading biotechnology company in London is seeking an experienced R&D Quality GCP Auditor. This role involves planning and participating in global audits of clinical trials, supporting regulatory inspections, and contributing to process improvements. The ideal candidate has a degree, extensive auditing experience, and excellent communication skills. Flexible work arrangements are offered, with travel to international destinations required.

Benefits

Generous Total Rewards Plan

Opportunities for learning and advancement

Inclusive community

Qualifications

• Degree educated.
• Extensive international auditing conduct experience.
• Experience in data mining and data analytics is advantageous.
• Excellent written and verbal communication skills.

Responsibilities

• Plan, conduct and report GCP compliance audits internationally.
• Serve as a lead auditor for complex GCP audits.
• Identify and communicate compliance risks.
• Host regulatory authority inspections.
• Contribute to R&D Quality process improvement initiatives.

Skills

GCP compliance

International auditing

Data analytics

Communication skills

Education

Degree

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.

R&D QUALITY GCP AUDITOR

LIVE

What you will do

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

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

Be part of our team

You would be joining Amgen’s R&D Quality 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 Quality audit team is part of Amgen\'s R&D Quality Group.

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:

• Degree educated
• Extensive international auditing conduct experience in GCP or as regulatory authority inspector
• Experience of data mining, manipulation and data analytics would be advantageous
• Excellent written and verbal communication 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

LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace. The role can entail up to 40% travel to international destinations

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.