At a Glance
- Tasks: Plan and conduct global audits of clinical trials to ensure compliance.
- Company: Join Amgen, a leading biotechnology company dedicated to serving patients.
- Benefits: Flexible work options, generous rewards, and opportunities for personal growth.
- Other info: Dynamic role with up to 40% international travel and career advancement opportunities.
- Why this job: Make a real impact in healthcare while working with a diverse team.
- Qualifications: Degree educated with extensive GCP auditing experience and strong communication skills.
The predicted salary is between 36000 - 60000 £ per year.
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.
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.
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GCP Quality Auditor in Cambridge employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and growth of our employees. As an EU Regulatory Affairs Manager, you will be part of a diverse and inclusive team dedicated to serving patients, with ample opportunities for professional development and a generous Total Rewards Plan. With flexible working arrangements from our offices in Cambridge, Uxbridge, or Lisbon, you can enjoy a fulfilling career while maintaining a healthy work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Quality Auditor in Cambridge
✨Tip Number 1
Network like a pro! Reach out to current or former employees at Amgen on LinkedIn. A friendly chat can give you insider info and maybe even a referral, which can really boost your chances.
✨Tip Number 2
Prepare for the interview by researching Amgen’s recent projects and values. Show us that you’re not just another candidate; you’re genuinely interested in how you can contribute to their mission of serving patients.
✨Tip Number 3
Practice your answers to common interview questions, especially around GCP compliance and auditing. We want to see that you can articulate your experience clearly and confidently.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re serious about joining the team.
We think you need these skills to ace GCP Quality Auditor in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the GCP Quality Auditor role. Highlight your auditing experience and any relevant qualifications to show us you’re the perfect fit!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you’re passionate about the role and how your background makes you an ideal candidate. Keep it engaging and personal!
Showcase Your Communication Skills:Since excellent written communication is key for this role, ensure your application is clear, concise, and free of errors. We want to see your ability to convey complex information effectively.
Apply Through Our Website:Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy to navigate!
How to prepare for a job interview at Amgen
✨Know Your GCP Inside Out
Make sure you brush up on Good Clinical Practice (GCP) guidelines before the interview. Familiarise yourself with the latest regulations and how they apply to clinical trials. This will show that you're not just knowledgeable but also genuinely interested in the role.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to describe how you would handle specific auditing situations. Think of examples from your past experience where you identified compliance risks or led audits. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Showcase Your Communication Skills
As a GCP Quality Auditor, you'll need to communicate effectively with various stakeholders. Be ready to discuss how you've successfully communicated complex information in the past. Practise articulating your thoughts clearly and confidently during the interview.
✨Demonstrate Your Team Spirit
Amgen values collaboration, so be prepared to talk about how you've worked within a team to achieve common goals. Share examples of how you contributed to process improvements or supported colleagues during audits. This will highlight your ability to fit into their culture.
