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 required.
The predicted salary is between 60000 - 80000 £ 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
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 employer: Amgen SA
At Amgen, we pride ourselves on being a leading biotechnology company that prioritises the well-being and professional growth of our employees. With a diverse and inclusive work culture, we offer vast opportunities for career advancement and a generous Total Rewards Plan that supports health, finance, and work/life balance. Join us in our state-of-the-art Cambridge or Uxbridge offices, where you can contribute to meaningful projects while enjoying flexible working arrangements.
StudySmarter Expert Advice🤫
We think this is how you could land Inspection Readiness Manager
✨Tip Number 1
Network like a pro! Reach out to folks 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 diving deep into Amgen's mission and values. Show us how your experience aligns with their goals, especially around inspection readiness and quality improvement.
✨Tip Number 3
Practice makes perfect! Mock interviews with friends or mentors can help you nail down your responses and boost your confidence before the real deal.
✨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 Inspection Readiness Manager
Some tips for your application 🫡
Show Your Passion:When you're writing your application, let your enthusiasm for the role shine through! We want to see how your experiences align with our mission to serve patients and how you can contribute to our team.
Tailor Your CV:Make sure to customise your CV for the Inspection Readiness Manager position. Highlight relevant experience in GCP and IVDR, and don’t forget to mention any continuous improvement initiatives you've led. We love seeing how you’ve made an impact!
Be Clear and Concise:Keep your application straightforward and to the point. Use clear language and avoid jargon where possible. We appreciate a well-structured application that makes it easy for us to see your qualifications and skills.
Apply Through Our Website:Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Amgen SA
✨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 where you’ve successfully managed inspection readiness or led process improvements. Highlight any experience you have with global clinical trials, as this will resonate well with the interviewers.
✨Ask Insightful Questions
Come prepared with questions that show your interest in Amgen’s mission and values. Ask about their approach to continuous improvement in inspection readiness and how they support their teams in achieving successful regulatory inspections.
✨Demonstrate Team Spirit
Since the role involves cross-functional collaboration, be ready to discuss how you’ve worked effectively within teams. Share examples of mentoring or developing others, as this aligns with the company’s focus on growth and community.
