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For Companies At a Glance
- Tasks: Plan and conduct global audits of clinical trials, ensuring compliance and quality.
- Company: Join Amgen, a leader in biotechnology with a commitment to innovation.
- Benefits: Flexible work options, generous rewards, and opportunities for career growth.
- Why this job: Make a real impact in clinical research while travelling internationally.
- Qualifications: Degree educated with extensive GCP auditing experience and strong communication skills.
- Other info: Be part of a diverse community that values your ideas and contributions.
The predicted salary is between 36000 - 60000 £ per year.
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
- 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.
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.
GCP Quality Auditor employer: WRITEMAN
Contact Detail:
WRITEMAN Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GCP Quality Auditor
✨Tip Number 1
Network like a pro! Reach out to professionals in the GCP auditing field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by brushing up on your GCP knowledge and recent trends in clinical trials. We want you to show off your expertise and passion for the role!
✨Tip Number 3
Practice your communication skills! Since you'll be reporting and discussing compliance risks, being clear and confident in your delivery is key. Try mock interviews with friends or mentors.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace GCP Quality Auditor
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the GCP Quality Auditor role. Highlight your international auditing experience and any relevant skills in data analytics. We want to see how your background fits with what we’re looking for!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about GCP compliance and how your experience aligns with our needs. Keep it engaging and personal – we love a good story!
Show Off Your Communication Skills: Since excellent written communication is key for this role, make sure your application is clear and concise. Avoid jargon and keep it professional yet approachable. We appreciate straightforwardness!
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, you’ll find all the info you need about the position there!
How to prepare for a job interview at WRITEMAN
✨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 any recent changes in the field. This will not only show your expertise but also demonstrate your commitment to quality in clinical trials.
✨Prepare for Scenario-Based Questions
Expect questions that ask you to describe how you would handle specific auditing situations or compliance risks. Think of examples from your past experience where you successfully identified issues or improved processes. This will help you showcase your problem-solving skills and practical knowledge.
✨Showcase Your Communication Skills
As a GCP Quality Auditor, you'll need to communicate effectively with various stakeholders. Prepare to discuss how you've successfully communicated complex information in the past, whether in reports or during audits. Practising clear and concise explanations will be key.
✨Highlight Your International Experience
Since this role involves global audits, emphasise any international auditing experience you have. Discuss the different cultures and regulatory environments you've navigated, and how that has shaped your approach to compliance. This will set you apart as a candidate who can adapt to diverse settings.
