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For Companies At a Glance
- Tasks: Lead quality assurance strategies for clinical trials and ensure compliance with regulations.
- Company: Join Amgen, a top biotech company dedicated to serving over 10 million patients globally.
- Benefits: Enjoy hybrid work options, generous rewards, and opportunities for personal and professional growth.
- Why this job: Be part of a dynamic team making a real impact in healthcare while developing your career.
- Qualifications: Experience in Quality Management and strong knowledge of Clinical R&D is essential.
- Other info: Flexible working from home with regular office visits in Cambridge or Uxbridge.
The predicted salary is between 48000 - 72000 ÂŁ per year.
Job Title: Quality Compliance Senior Manager
Job Location: Cambridge, UK
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level:
HOW MIGHT YOU DEFY IMAGINATION?
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.
QUALITY COMPLIANCE SENIOR MANAGER
What You Will Do
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, for all stages of products in the clinical development program. You will 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)
Be part of our team
We are hiring two Quality Compliance Senior Managers, each one will be joining a dynamic and expanding team, operating within one of the following therapy areas: General Medicine, Biosimilars and/or Inflammation.
What We Expect Of You
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:
- 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
- Experience 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
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
LOCATION: Ability to work flexibly from home with regular office work either from our Cambridge or Uxbridge next generation workspace.
APPLY NOW
for a career that defies imagination. In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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.
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Quality Compliance Senior Manager employer: Lifelancer
Contact Detail:
Lifelancer Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Compliance Senior Manager
✨Tip Number 1
Familiarize yourself with the latest Good Clinical Practices (GCP) guidelines and regulations. Being well-versed in these standards will not only help you during interviews but also demonstrate your commitment to quality compliance.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotech industries, especially those who have experience in quality management and assurance. Engaging with industry peers can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of how you've managed quality events or conducted audits in previous roles. Highlighting your hands-on experience will showcase your expertise and readiness for the Quality Compliance Senior Manager position.
✨Tip Number 4
Stay updated on the latest technologies used in data collection and measurement within clinical trials. Being knowledgeable about tools like Veeva or TrackWise can set you apart as a candidate who is ready to contribute from day one.
We think you need these skills to ace Quality Compliance Senior Manager
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Quality Compliance Senior Manager position. Understand the key responsibilities and required qualifications, as this will help you tailor your application effectively.
Highlight Relevant Experience: In your CV and cover letter, emphasize your experience in Quality Management and Quality Assurance within the pharmaceutical or biotech industry. Be specific about your expertise in GCP and any relevant systems like Veeva or TrackWise.
Showcase Your Skills: Make sure to highlight your strong analytical, decision-making, and communication skills. Provide examples of how you've successfully led teams or mentored others, as leadership experience is considered a plus for this role.
Tailor Your Application: Customize your cover letter to reflect your passion for serving patients and your alignment with Amgen's mission. Mention how your unique contributions can support their goals in quality compliance and clinical trials.
How to prepare for a job interview at Lifelancer
✨Showcase Your Expertise in Quality Management
Be prepared to discuss your experience in Quality Management and Quality Assurance, particularly in the pharmaceutical or biotech industry. Highlight specific examples where you implemented risk-based quality practices and how they positively impacted clinical trials.
✨Demonstrate Knowledge of GCP and Auditing
As a Good Clinical Practices (GCP) Subject Matter Expert, you should be ready to explain your understanding of GCP guidelines. Discuss your experience conducting audits and managing inspections, and provide insights into how you've handled quality events in the past.
✨Communicate Effectively
Strong communication skills are essential for this role. Practice articulating your thoughts clearly and concisely. Be prepared to engage in active listening during the interview, showing that you value the perspectives of others, especially when discussing quality and compliance risks.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your analytical and decision-making skills. Think about past experiences where you had to analyze data quality trends or manage regulatory inspections, and be ready to discuss your approach and the outcomes.
