At a Glance
- Tasks: Lead quality assurance for clinical trials and ensure compliance with global regulations.
- Company: Join a leading biotech firm focused on innovative obesity treatments.
- 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 clinical trial oversight; strong analytical and communication skills.
The predicted salary is between 60000 - 80000 £ per year.
In this vital role you will 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.
You will operate within. Serve as the GCP quality SME, providing independent quality guidance for clinical trial activities 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.
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.
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.
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 Compliance Manager in Cambridge employer: Amgen, Inc.
Amgen is an exceptional employer that fosters a diverse and inclusive work environment, empowering employees to contribute their ideas and advance their careers within the global organisation. With generous benefits that support health, finance, and work/life balance, alongside vast opportunities for professional growth, working in our state-of-the-art Cambridge or Uxbridge locations offers a unique chance to be part of innovative clinical development in the Obesity Therapeutic Area.
StudySmarter Expert Advice🤫
We think this is how you could land GCP Quality Compliance Manager in Cambridge
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those who work at companies you're eyeing. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by practising common questions and scenarios related to GCP and quality compliance. We recommend doing mock interviews with friends or using online platforms to get comfortable and confident.
✨Tip Number 3
Showcase your expertise! Bring examples of how you've tackled quality issues or improved processes in past roles. This will demonstrate your hands-on experience and problem-solving skills to potential employers.
✨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 genuinely interested in joining our team.
We think you need these skills to ace GCP Quality Compliance Manager in Cambridge
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that align with the GCP Quality Compliance Manager role. Highlight your experience in clinical R&D and quality management, and don’t forget to mention any relevant tools 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 background makes you a perfect fit for our team. Keep it engaging and personal!
Showcase Your Communication Skills:Since excellent written communication is key for this role, make sure your application is clear and concise. Use professional language but let your personality come through – we want to see the real you!
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 you need about the role and our company culture there!
How to prepare for a job interview at Amgen, Inc.
✨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 or implemented corrective actions. This will show that you can simplify complex processes and contribute to quality oversight effectively.
✨Engage with Stakeholders
Since communication is key in this role, practice articulating your thoughts clearly. Be prepared to discuss how you've engaged with various stakeholders in previous positions. Highlight your ability to convey complex information in a straightforward manner.
✨Familiarise Yourself with Quality Management Systems
If you have experience with electronic Quality Management Systems like Veeva or TrackWise, make sure to mention it. If not, do some research on these systems and be ready to discuss how they fit into clinical trial oversight processes. This shows you're proactive and eager to learn.
