R&D Quality GCP Auditor
R&D Quality GCP Auditor
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Job Description
Career Category
ComplianceJob Description
HOW MIGHT YOU DEFY IMAGINATION
If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
R&D QUALITY GCP AUDITOR
LIVE
What you will do
In this vital role within R&D Quality you will be planning and participating in global audits of Amgens 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 Amgens R&D Quality Audit Team of expert professional and widely experienced individuals working with a global remit across Amgens portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgens 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
- Extensive international auditing conduct experience in GCP or as regulatory authority inspector
- 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
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.
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.
.Employment Type
Full-Time
