Quality Compliance Manager

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 MANAGER

LIVE

What you will do

In this vital role you will provide quality support for the development and implementation of a risk-based quality assurance strategy for all stages of products in non-clinical development, with the main focus of maintaining the integrity of Amgen's research data. You will be covering both regulated and non-regulated research, including Good Laboratory Practice (GLP).

• Support GLP compliance oversight through cross-functional collaboration with functional areas and stakeholder groups within Research in alignment with standard practices
• Plan, conduct and report out on risk-based R&D audits. Review, negotiate and approve responses to R&D audit findings and provide oversight for compliance activities through to finding closure
• Manage deliverables and provide data and recommendations regarding the state of quality for processes, technology, laboratory and external vendor performance
• Support the establishment of regional expertise to ensure quality and compliance to local regulations as well as support research-specific data integrity, including technologies for data collection and measurement
• Support Research for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management, compliance related questions and critical issues
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

Be part of our team

You would be joining a newly created team that brings significant field experience and industry knowledge, well-integrated across all therapeutic areas.

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
• Experience with Quality Oversight of Nonclinical Trials, including auditing GLP phases, data and final reports, as well as partnership with third-party vendors, suppliers and partners
• Oversight of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise
• Detailed understanding of R&D activities and Global Regulations
• Knowledge of the Regulatory Submission and Inspection Management procedures
• Excellent verbal and written communication skills, including significant 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 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.

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.