At a Glance
- Tasks: Lead quality assurance strategies for clinical trials and ensure compliance with global regulations.
- Company: Join a leading biotech firm focused on innovative healthcare solutions.
- Benefits: Flexible work options, generous rewards, and opportunities for career growth.
- Other info: Be part of a diverse team that values your ideas and contributions.
- Why this job: Make a real impact in clinical development while advancing your career in a supportive environment.
- Qualifications: Experience in GCP and strong analytical skills are essential.
The predicted salary is between 60000 - 80000 £ per year.
What you will do
- Provide proactive end-to-end quality support for the development and implementation of a risk-based quality assurance strategy that advances quality by design principles for the full clinical development program, including protocol development, database lock, and regulatory submissions/approvals.
- Oversee quality management and ensure compliance for global and local clinical trials.
- Serve as the GCP quality SME, providing independent quality guidance aligned with global regulations and best practices.
- Oversee quality and compliance across all stages of clinical development programs, including risk management through RACT, and protection of patient safety, rights, and data integrity.
- Support clinical trial teams with quality management activities such as deviations/CAPAs, inspection readiness, serious breaches, privacy issues, and regulatory inspection responses.
- Review protocols and trial processes to drive simplification, apply lessons learned, and identify critical data and operational risks.
- Implement innovative, risk-based quality oversight approaches using advanced analytics, AI, and NLP methodologies.
- Monitor and analyze quality metrics and trends, identify gaps, and recommend corrective and preventive actions to stakeholders and senior leadership.
- Provide vendor quality oversight and support regional compliance with local regulations and regulatory requirements.
- Plan, conduct, and report risk-based GCP audits, including investigator site, affiliate, and study-level audits.
Be part of our team
You would be joining the R&D Quality team, operating within the Obesity Therapeutic Area.
What we expect of you
- Strong experience in GCP within Clinical R&D, Quality, or Study Management environments.
- Knowledge of electronic Quality Management Systems (e.g., Veeva, TrackWise) and clinical trial oversight processes.
- Solid understanding of clinical development, protocol execution, regulatory submissions, and inspection management.
- Proven ability to support operational and quality oversight of clinical trials from development through submission.
- Excellent written and verbal communication skills, including business writing and stakeholder engagement.
- Strong analytical, critical-thinking, and problem-solving capabilities with the ability to simplify complex processes and technical concepts.
- Background in Quality Management/Assurance and risk-based quality approaches within the pharmaceutical or biotech industry is preferred.
- Degree educated in a relevant field.
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.
GCP Quality Compliance Manager 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 innovation in the field of clinical development. With flexible working arrangements from our state-of-the-art Cambridge or Uxbridge offices, we offer extensive opportunities for professional growth and a comprehensive Total Rewards Plan that prioritises health, work/life balance, and career advancement.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Quality Compliance Manager
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already working in GCP or clinical R&D. A friendly chat can lead to insider info about job openings and even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP regulations and quality management systems. We want you to shine when discussing how you can contribute to our risk-based quality assurance strategy!
✨Tip Number 3
Showcase your problem-solving skills! Be ready to share examples of how you've simplified complex processes or tackled challenges in previous roles. This will demonstrate your analytical capabilities and fit for the role.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, it shows you’re genuinely interested in being part of our diverse and inclusive community.
We think you need these skills to ace GCP Quality Compliance Manager
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the GCP Quality Compliance Manager role. Highlight your experience in clinical R&D and quality management, and don’t forget to mention any relevant systems like Veeva or TrackWise!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about quality assurance in clinical trials and how your skills align with our needs. Keep it concise but impactful!
Showcase Your Communication Skills:Since excellent written communication is key for this role, make sure your application is clear and professional. Avoid jargon unless it’s necessary, and ensure everything flows nicely.
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 and shows us you’re serious about joining our team!
How to prepare for a job interview at Amgen Inc. (IR)
✨Know Your GCP Inside Out
Make sure you brush up on your Good Clinical Practice (GCP) knowledge. Understand the latest regulations and best practices, as you'll need to demonstrate your expertise in quality compliance during the interview. Be ready to discuss how you've applied these principles in past roles.
✨Showcase Your Analytical Skills
Prepare to talk about your experience with risk management and quality metrics. Think of specific examples where you've identified gaps and implemented corrective actions. This will show that you can simplify complex processes and contribute to quality oversight effectively.
✨Familiarise Yourself with Quality Management Systems
If you have experience with electronic Quality Management Systems like Veeva or TrackWise, be sure to highlight this. Discuss how you've used these tools to enhance compliance and streamline clinical trial processes, as this is crucial for the role.
✨Engage with Stakeholders
Communication is key! Prepare to share examples of how you've engaged with various stakeholders in previous roles. Highlight your ability to convey complex information clearly and how you've built relationships to support quality management activities.
