At a Glance
- Tasks: Lead inspection readiness for clinical trials and drive quality improvement initiatives.
- Company: Join Amgen, a leader in biopharmaceutical innovation.
- Benefits: Flexible work options, generous rewards, and career growth opportunities.
- Other info: Be part of a diverse team that values your ideas and contributions.
- Why this job: Make a real impact on clinical trial integrity and participant safety.
- Qualifications: Degree in life sciences and experience in clinical research preferred.
The predicted salary is between 60000 - 80000 £ per year.
What you will do
- Lead GCP and IVDR Inspection Readiness and Preparation activities across Amgen’s clinical portfolio, including early-phase, late-phase, and observational studies.
- 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.
Be part of our team
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.
What we expect of you
- 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
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.
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.
Inspection Readiness Manager in Uxbridge employer: Amgen Inc. (IR)
Amgen is an exceptional employer that fosters a diverse and inclusive work environment, empowering employees to contribute their ideas and drive continuous improvement in clinical operations. With generous benefits and vast opportunities for professional growth, including flexible working arrangements from our state-of-the-art Cambridge or Uxbridge locations, Amgen prioritises the well-being of its team members while ensuring the integrity and quality of clinical trial data.
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 folks in the industry, especially those who work at Amgen or similar companies. A friendly chat can open doors and give you insider info on what they’re really looking for.
✨Tip Number 2
Prepare for interviews by diving deep into GCP and IVDR guidelines. Brush up on your knowledge about inspection readiness strategies and be ready to share how you’ve tackled challenges in past roles. We want to see your expertise shine!
✨Tip Number 3
Showcase your continuous improvement mindset! Think of examples where you identified quality trends or implemented effective solutions. This will demonstrate your proactive approach and fit with our culture of innovation.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining our team and contributing to our 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, and don’t forget to mention any relevant projects you've led or contributed to.
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 specific about your achievements and how they relate to the job.
Showcase Continuous Improvement Mindset:We love candidates who are proactive about quality and improvement. In your application, share examples of how you've identified trends or risks in past roles and what solutions you implemented. This will show us your problem-solving 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 Inc. (IR)
✨Know Your Stuff
Make sure you brush up on GCP and IVDR regulations before the interview. 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. Highlight any process improvements you've implemented and how they positively impacted inspection outcomes.
✨Ask Smart Questions
Come prepared with insightful questions about the team and their current challenges. This shows your genuine interest in the role and helps you understand how you can contribute to their continuous improvement initiatives.
✨Be a Team Player
Emphasise your ability to work cross-functionally. Share experiences where you partnered with other teams to enhance operational quality or support successful regulatory inspections, as collaboration is key in this role.
