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.
GCP / GLP Senior Associate Compliance
What you will do
In this vital role you will support the compliance team to provide proactive GCP compliance oversight to functional areas and partner groups within the R&D organization.
Process improvement opportunities and best practices within QCA compliance workload that will contribute to overall operational effectiveness as well as support QMS improvements and processes including systems.
Manage and maintain GCP / GLP compliance documents, tools and SharePoint site, e.g. inspection distribution list, onboarding documentation, compliance manual, team meeting minutes etc.
Facilitate R&D inspection readiness activities
Maintain knowledge of current systems, tools, best practices and terminology
Working across teams managing priorities.
Support Deviation Management Process
Initiate, support and update deviation records in RDCS to ensure accurate documentation of deviations and CAPAs in RDCS per deviation management process.
Compliance TA Work
Global Annual Risk Assessment Process Manage and update tools to support annual risk assessment.
Support Compliance Leads in the following areas :
Deviation management process by conducting review / investigation of minor deviations to close out.
Risk management process
Audit planning, eg RAT, PAP creation under supervise.
GCP inspection readiness and inspection management activities
Be part of our team
As a member of Amgen’s Compliance team, the Compliance Senior Associate supports the provision of proactive GCP compliance oversight to functional areas and stakeholder groups within the R&D organization.
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 :
Master's degree OR Bachelor's degree
Proven working knowledge of regulatory and compliance standards within the Pharma / Biotech industry
Experience working within GXP compliance
General knowledge of global GXP regulations
General knowledge GXP processes and operations in the bio-pharmaceutical industry
Proven knowledge in SharePoint or Cloud technologies
Understanding of audit / compliance program design
General Knowledge of regulatory authority inspection processes
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
A flexible working from home policy.
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