At a Glance
- Tasks: Lead inspection readiness for clinical trials and drive continuous improvement initiatives.
- Company: Join Amgen, a leading biotechnology company dedicated to serving patients worldwide.
- Benefits: Flexible work options, generous rewards, and opportunities for personal and professional growth.
- Other info: Be part of a diverse team that values your unique contributions and ideas.
- Why this job: Make a real impact in clinical research while supporting patient safety and data integrity.
- Qualifications: Degree in life sciences and experience in clinical trials or biopharmaceuticals.
The predicted salary is between 55000 - 65000 £ per year.
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.
In this vital role, you will lead GCP and IVDR Inspection Readiness and Preparation activities across Amgen’s clinical portfolio, including early-phase, late-phase, and observational studies. You will drive inspection readiness strategies, oversee site inspection preparation projects, and partner cross-functionally to strengthen operational quality, support successful regulatory inspections, and promote continuous improvement across the organization.
- Lead GCP and IVDR site inspection readiness and preparation activities, ensuring consistent execution and successful inspection outcomes.
- Manage inspection readiness tools, systems, materials, and regulatory inspection preparation processes.
- Drive continuous improvement initiatives by identifying quality trends, risks, and inspection learnings, and implementing effective solutions.
- Partner with the Inspection Readiness Support Team to advance study health, quality, and inspection readiness initiatives.
- Serve as a subject matter advisor on inspection readiness and support selected internal audit activities.
- Maintain inspection readiness SharePoint resources, inspection documentation repositories, and access management.
- Support the Inspection Readiness & Operational Quality Senior Manager in strategic and operational activities.
- Mentor and develop student interns.
You would be joining the Operational Quality team who supports Clinical Program Operations by providing inspection readiness, Trial Master File, and clinical trial risk management expertise to ensure compliance with ICH GCP. Through these activities, the team helps protect trial participant rights, safety, and well-being while ensuring the integrity, quality, and credibility of clinical trial data.
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
- Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
- Experience of, or oversight of global clinical trial conduct
- Experience driving and leading process development and/or improvement
- Experience as an Inspection, or Risk Manager is preferred
- Mandarin language is preferred but not mandatory
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.
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Inspection Readiness Manager in Uxbridge employer: Amgen
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and professional growth of our employees. With a strong focus on collaboration and innovation, our Operational Quality team fosters a diverse and inclusive work culture where every voice is valued. Enjoy flexible working arrangements from our state-of-the-art Cambridge or Uxbridge offices, alongside a generous Total Rewards Plan that supports your health, career development, and work-life balance.
StudySmarter Expert Advice🤫
We think this is how you could land Inspection Readiness Manager in Uxbridge
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Amgen. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff! Brush up on GCP and IVDR guidelines, and be ready to discuss how you've driven inspection readiness in past roles. Show them you're the expert they need!
✨Tip Number 3
Don’t just apply—engage! When you submit your application through our website, follow up with a quick email to express your enthusiasm. It shows initiative and keeps you on their radar.
✨Tip Number 4
Be ready to showcase your problem-solving skills. Think of examples where you've identified quality trends or implemented improvements. This is your chance to shine and show how you can contribute to Amgen's mission!
We think you need these skills to ace Inspection Readiness Manager in Uxbridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the Inspection Readiness Manager role. Highlight your GCP and IVDR experience, as well as any relevant clinical trial work you've done. We want to see how you can contribute to our mission!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to tell us why you're passionate about inspection readiness and how your background makes you a perfect fit for our team. Be genuine and let your personality come through—this is your moment to connect with us.
Showcase Continuous Improvement Initiatives:In your application, don’t forget to mention any continuous improvement initiatives you've led or been part of. We love seeing candidates who are proactive about enhancing processes and quality, so share those experiences with us!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, you’ll find all the details about the role and our company culture there. Let’s make this happen together!
How to prepare for a job interview at Amgen
✨Know Your Stuff
Make sure you brush up on Good Clinical Practice (GCP) and In Vitro Diagnostic Regulation (IVDR) guidelines. Familiarise yourself with Amgen’s clinical portfolio and be ready to discuss how your experience aligns with their inspection readiness strategies.
✨Showcase Your Experience
Prepare specific examples from your past roles that demonstrate your ability to lead inspection readiness activities and drive continuous improvement. Highlight any relevant projects where you managed inspection tools or partnered cross-functionally.
✨Ask Insightful Questions
Come prepared with questions that show your interest in the role and the company. Ask about their current challenges in inspection readiness or how they foster a culture of continuous improvement within the team.
✨Be Yourself
Amgen values diversity and unique contributions, so don’t hesitate to let your personality shine through. Share your passion for serving patients and how you can contribute to their mission while being authentic in your responses.
