GCP Quality Auditor

Amgen; Aberdeen City; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A leading biotechnology company is seeking a GCP Quality Auditor in the United Kingdom. The role involves planning and participating in international audits of clinical trials activities and supporting regulatory inspections. The ideal candidate will have extensive GCP auditing experience and strong communication skills. The position allows for flexible working arrangements with occasional international travel.

Benefits

Generous Total Rewards Plan

Opportunities for professional development

Inclusive corporate culture

Qualifications

• Degree educated.
• Proven and extensive international auditing experience in GCP.
• Experience of data mining, manipulation, and data analytics would be advantageous.
• Excellent written and verbal communication skills.

Responsibilities

• 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 play a role in regulatory authority inspections.
• Contribute to R&D Quality process improvement initiatives.
• Author and contribute to development of R&D Quality cross-functional controlled documents.

Skills

International auditing experience in GCP

Data mining and manipulation

Excellent written communication

Excellent verbal communication

Education

Degree in a related field

Job description

Overview

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.

GCP QUALITY 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.

Key responsibilities include:

• 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.

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
• Proven and extensive international auditing experience in GCP
• Experience of data mining, manipulation and data analytics would be advantageous
• Excellent written and verbal communication skills

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

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

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.