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Job Description

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.

Compliance Senior Manager

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide independent and objective compliance advice and oversight to the business in support GCP and GLP activities in order to strengthen and advance Amgen’s R&D QMS

• Assess and manage risk, including providing input into the development of the annual audit program

• Collaborate with other Amgen compliance/quality functions to ensure aligned and comprehensive compliance support for R&D GCP, GLP and Research programs

• Participate as compliance representative in evaluating, qualifying and providing oversight of GCP/GLP vendors

• Participate in due diligence activities for potential business development deals

• Ensure escalation of significant compliance matters to appropriate compliance/quality oversight bodies and participate in compliance investigations

• Prepare, analyze and communicate compliance metrics (e.g., audit and inspection data) and other significant compliance information on periodic basis to key stakeholders and senior R&D management

• Maintain knowledge of current regulatory and compliance practices/issues and provide continuous training and education to R&D staff on relevant information

• Triage and/or manage as appropriate R&D GCP/GLP compliance matters arising in assigned geographic region

• Support activities related to GxP inspections - preparation, conduct and close out and response review

• Provide compliance oversight for Amgen programs for all stages of products in clinical and/or laboratory development

• Provide ISA, IPA, SPA support pre-meetings, debriefs, Audit plan outlines, response review and risk management

• Contribute to Continuous Improvement Initiatives and improve R&D processes by contributing expertise in identifying robust CAPAs

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 a candidate with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Regulatory & Compliance experience

Or

Master’s degree and 6 years of Regulatory & Compliance experience

Or

Bachelor’s degree and 8 years of Regulatory & Compliance experience

Or

Associate’s degree and 10 years of Regulatory & Compliance experience

Or

High school diploma / GED and 12 years of Regulatory & Compliance experience

Preferred Qualifications:

• Degree educated in appropriate subject area with proven experience gained in the biopharmaceutical industry

• GCP / GLP Quality Assurance Qualification

• Experience supporting regulatory authority inspection of pre-clinical, clinical research, laboratory research and/or pharmacovigilance activities

• Compliance programme or project management

• Thorough knowledge of GCP / GLP regulations

• Understanding of audit/compliance program design

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also 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

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