GCP Quality Auditor

Amgen Inc. (IR); Cambridge, Uxbridge; Hybrid; GBP 65,000 - 90,000; Full time

Job summary

Amgen Inc. (IR) seeks a GCP Quality Auditor to plan, conduct, and report international audits of clinical trials activities. The role supports regulatory inspections and facilities, joining a global R&D Quality Audit Team.

Travel and flexible work from home with regular office work in Cambridge or Uxbridge are expected. Ideal candidates hold a degree and have extensive GCP audit experience, with strong written and verbal communication skills to communicate risks and drive process improvements

Qualifications

• Degree educated and experienced in GCP audits.
• Proven and extensive international auditing experience in GCP.
• Experience with 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 development of R&D Quality cross-functional controlled documents.

Skills

GCP auditing

International auditing

Data analytics

Written and verbal communication

Education

Degree educated

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 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.

• 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.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen