GCP Quality Auditor

Amgen, Inc.; Uxbridge; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A global biotechnology company seeks a GCP Quality Auditor to plan and conduct compliance audits of clinical trials. The role involves identifying compliance risks and supporting regulatory inspections while offering opportunities for career development within a diverse and inclusive team. Candidates should have a degree and extensive GCP auditing experience. Flexibility for remote work is available, with possible international travel up to 40%.

Benefits

Generous Total Rewards Plan

Opportunities to learn and grow

Supportive work environment

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/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.

Skills

International auditing experience in GCP

Data mining and data analytics

Excellent communication skills

Education

Degree

Job description

Career Category

Compliance

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 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.

WIN

What you can expect of us.

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.

THRIVE

What you can expect of us.

What you can expect of us

• 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.

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.