Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. 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, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Compliance Manager

Live

What you will do

Let’s do this. Let’s change the world.

The role of the GxP (GCP and GLP) Compliance Manager is to support the provision of proactive GxP (GCP and GLP) compliance oversight and guidance to functional areas and partner groups within the R&D organization. Activities are to be performed under supervision of Compliance Senior Manager and/or Director GxP Compliance. Open to remote or onsite in both US and UK.

• Entering and updating records in RDCS based on investigation and deviation meetings and tracking through to closure

• Supporting GCF Level 6 investigation lead in RCA & effectiveness verification activities of CAPAs

• Collating and verifying objective evidence for inspection & audit-driven CAPAs

• Assessing quality and accuracy of data in RDCS and reporting on RDCS status, progress and activities, as required based on regulations and guidance from GCF Level 6

• Data entry into the risk assessment tool (using risk assessment methodology)

• Support Safety, Global Development and Global Research teams in GxP inspection readiness and inspection management activities

• Support R&D Compliance on governance bodies in the clinical development, pharmacovigilance and/or research area

• Support the GxP compliance team as needed with functional activities including deviation management, inspection readiness, administration of compliance committees

• Maintain knowledge of current regulatory and compliance practices/issues

• Collate compliance metrics (e.g. audit/inspection data and other significant compliance information) to support presentations to key team members

• Support the team in annual and quarterly ISA (investigator site audit) planning and subsequent activities leading to audit execution and preparation of audit certificate

• Support the team in annual and quarterly SPA (service provide audit) planning and management

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek is an employee with these qualifications.

Doctorate degree

OR

Master’s degree and 2 years of compliance experience

Or

Bachelor’s degree and 4 years of compliance experience

Or

Associate’s degree and 10 years of compliance experience

Or

• High school diploma / GED and 12 years of compliance experience

Thrive

Some of the vast rewards of working here

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.

• Full support and career-development resources to expand your skills, enhance your expertise, and improve your potential along your career journey

• A 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—with compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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