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- Tasks: Lead quality assurance strategies for clinical trials and audits, ensuring compliance and risk management.
- Company: Join Amgen, a top biotech company dedicated to serving over 10 million patients globally.
- Benefits: Enjoy flexible working options, generous rewards, and a supportive community focused on growth.
- Why this job: Be part of a mission-driven team that values innovation, collaboration, and making a real impact.
- Qualifications: Experience in Quality Management within pharma/biotech, with strong GCP knowledge and leadership skills.
- Other info: Work from home or at our modern Cambridge or Uxbridge offices.
The predicted salary is between 48000 - 84000 ÂŁ 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.
What you will do
- Provide proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy, for all stages of products in the clinical development program.
- Support global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.
- Serve as a Good Clinical Practices (GCP) Subject Matter Expert, providing independent quality guidance for clinical trials.
- Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits) or support outsourced audits.
- Manage quality events and regulatory inspections, and advise on responses, including root cause analysis and CAPA plans.
- Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) to identify and mitigate trial risk.
- Support monthly meetings with clinical program leaders to review quality and compliance risks, including deviations, trends, filing timelines, inspections, and cross-program risks.
- Conduct new vendor qualifications in a risk-based manner.
- Analyze data quality trends, address areas of weakness and gaps, implement and communicate key quality metrics.
- Coordinate and support key technologies for data collection and measurement (e.g., biomarker usage and imaging methods).
What we expect of you
- Experience in Quality Management, Quality Assurance, or other relevant risk-based quality practices in the pharmaceutical/biotech industry.
- Expertise in Quality Management Systems (QMS), including electronic systems like Veeva or TrackWise.
- Strong knowledge of Clinical R&D, global regulations and regulatory submissions.
- Quality Oversight of Clinical Trials, including protocol development, execution and submissions.
- Expert within GCP, including conducting audits and managing inspections.
- Excellent communication, active listening, strong analytical and decision-making skills.
- Leadership or mentoring experience is considered a plus.
- Degree educated.
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. Please contact us to request an accommodation.
Quality Compliance Senior Manager (GCP) employer: Amgen
Contact Detail:
Amgen Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Compliance Senior Manager (GCP)
✨Tip Number 1
Familiarise yourself with the latest Good Clinical Practices (GCP) guidelines and any recent changes in regulations. This will not only enhance your knowledge but also demonstrate your commitment to quality compliance during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotech industries, especially those who have experience in quality management and assurance. Attend relevant conferences or webinars to make connections that could lead to valuable insights or referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed quality events or audits in previous roles. Highlight your analytical skills and decision-making processes to showcase your expertise in risk-based quality practices.
✨Tip Number 4
Research Amgen's current projects and initiatives in clinical development. Being knowledgeable about their work will allow you to tailor your responses during interviews and show your genuine interest in contributing to their mission.
We think you need these skills to ace Quality Compliance Senior Manager (GCP)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in Quality Management and Quality Assurance, particularly within the pharmaceutical or biotech industry. Emphasise your expertise in Good Clinical Practices (GCP) and any specific systems like Veeva or TrackWise.
Craft a Compelling Cover Letter: Write a cover letter that connects your skills and experiences directly to the responsibilities outlined in the job description. Mention your experience with risk-based quality assurance strategies and how you can contribute to Amgen's mission of serving patients.
Showcase Leadership Skills: If you have leadership or mentoring experience, be sure to highlight this in your application. Discuss specific instances where you led a team or mentored colleagues, as this aligns with the expectations for the role.
Demonstrate Analytical Skills: Provide examples in your application that showcase your strong analytical and decision-making skills. This could include situations where you conducted audits, managed inspections, or addressed data quality trends effectively.
How to prepare for a job interview at Amgen
✨Showcase Your GCP Expertise
As a Quality Compliance Senior Manager, you'll need to demonstrate your deep understanding of Good Clinical Practices. Be prepared to discuss specific examples from your past experiences where you provided quality guidance or conducted audits, highlighting your role as a subject matter expert.
✨Discuss Risk Management Strategies
Since this role involves developing risk-based quality assurance strategies, come ready to talk about how you've previously identified and mitigated risks in clinical trials. Share any tools or methodologies you've used, such as the Risk Assessment Categorization Tool (RACT), to illustrate your proactive approach.
✨Emphasise Communication Skills
Excellent communication is key in this position. Prepare to give examples of how you've effectively communicated with cross-functional teams or during inspections. Highlight your active listening skills and how they have helped you in resolving quality issues or managing stakeholder expectations.
✨Prepare for Leadership Questions
If you have leadership or mentoring experience, be ready to discuss it. Think of instances where you've led a team or mentored colleagues in quality management practices. This will show your ability to guide others and contribute to a collaborative work environment.
