GCP Quality AuditorUxbridge, GBRPosted 89 days ago

Kroes Communications; Uxbridge; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A global biotechnology company is seeking a GCP Quality Auditor to join their team in Uxbridge. In this role, you will conduct international audits and ensure compliance with GCP standards. Candidates should possess a degree and extensive GCP auditing experience, with strong communication skills. The position offers flexible work arrangements, including home office and potential travel. Join a diverse workplace dedicated to improving lives and advancing your career in a supportive environment.

Benefits

Generous Total Rewards Plan

Opportunities for career development

Inclusive community environment

Qualifications

• 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 regulatory authority inspections.
• Contribute to R&D Quality process improvement initiatives.
• Author and contribute to development of controlled documents.

Skills

International auditing experience in GCP

Excellent written communication skills

Data analytics

Education

Degree educated

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

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

• 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

• 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.