AddressHOW 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.
CLINICAL QUALITY MANAGER
LIVE
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 the clinical development program. Reporting to the Clinical Quality Senior Manager, Clinical & Research Quality (CRQ), you will support global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.
We are hiring two Clinical Quality Managers, each one will operate within one of the following Therapeutic Areas (TA): Oncology/Biosimilars or General Medicine.
- Provide quality oversight for Amgen programmes for all stages of products in clinical development
- Plan, conduct and report out on risk-based Good Clinical Practices (GCP) audits (investigator site audits, affiliate audits, and study level audits)
- Ensure quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to guarantee the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare and rights
- Support the establishment of regional expertise to ensure quality and compliance to local regulations
- Ensure TA-specific data integrity, including technologies for data collection and measurement (e.g., biomarker usage and imaging methods)
- Support Clinical Trial Teams for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management activities, and Serious Breaches/ Privacy Issues
- Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods leveraging AI and Natural Language Processing, and other advanced data analytics methods)
- Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes
WIN
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 areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility
- Oversight and implementation of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
- Thorough understanding of Clinical R&D activities and Global Regulations
- Knowledge of the Regulatory Submission and Inspection Management procedures
- Quality Oversight of Clinical Trials, including clinical trial protocol development, execution, and submissions
- Excellent verbal and written communication skills, including strong business writing abilities and active listening
- Ability to transform business and stakeholder feedback into clear, efficient processes using a straightforward language and format
- Strong analytical, critical-thinking and decision-making abilities
- Degree educated
THRIVE
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 or in our next generation work space in Cambridge or Uxbridge.
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.
careers.amgen.com
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.
