GCP Quality Auditor

Amgen SA; United Kingdom; Hybrid; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Global exposure

Professional growth

Total rewards package

Work-life balance

Job summary

Amgen is seeking a GCP Quality Auditor to join its R&D Quality Audit Team, with flexible home/office work from Cambridge or Uxbridge and up to 40% travel. You will plan and perform global audits of clinical trials activities and may support regulatory inspections of sites and facilities.

Responsibilities include planning/conducting GCP audits internationally, acting as lead auditor for complex audits, and communicating compliance risks to R&D Quality.

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 GCP audits across international sites.
• Serve as lead auditor for complex GCP audits.
• Identify and communicate GCP compliance risks to R&D Quality management.
• Host and/or participate in regulatory authority inspections.
• Contribute to or lead R&D Quality process improvement initiatives.
• Author and contribute to cross functional controlled documents

Skills

GCP auditing

Cross-border audits

Regulatory communication

Data analytics

Education

Bachelor's degree

Tools

Regulatory databases

Job description

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.

• 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
• 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

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

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.