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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.

Senior Manager Global Quality Compliance

Live

What you will do

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

• Develops and manages the audit program and annual audit plans to ensure that Amgen sites, Contract facilities, Quality Management Systems and Affiliates are periodically audited to assess compliance all applicable regulations and to identify potential risks.

• Leads or participates in critical Audits of Amgen Quality Management System, Amgen sites, Contract facilities, Affiliates and Critical Service providers, to identify and escalate top compliance risks.

• Ensures assignment, maintenance and sustainability of training and knowledge of staff per their specific roles to support the audit process

• Maintains up to date knowledge on latest standards, regulations, and industry trends.

• Ensures assessment of the state of compliance with appropriate regulations and participation in the assessment of action plans to correct deficiencies.

• Provides technical and organizational leadership toward resolving site and multi-site compliance issues.

• Alerts management of quality, and compliance risks.

• Provides support and presents on audit program for domestic and international Regulatory Authority Inspections when necessary.

• Serves as senior Corporate Quality Compliance representative on cross-functional teams (e.g., QMS, GPO, ALF and special task forces) and interacts with other departments in order to achieve goals.

• Interacts with other functional leads to ensure that Amgen Standards, strategies and direction are aligned with existing regulations and regulatory expectations.

• Establishes audit teams Goals by cascading from the functional area goals.

• Monitors and escalates to senior management and management review established Metrics representative of the health of the audits and inspections process.

• Supports Continual Improvement initiatives, programs and projects.

• Serves as the GPO for the Audits and Inspections QMS Quality Process, as appointed.

• Owns, revises, and periodically reviews procedures associated with Global Quality Compliance

• Owns and resolves deviations, CAPAs, and effectiveness verifications related to Global Quality Compliance.

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 will have these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of compliance experience

Or

Master's degree and 6 years of compliance experience

Or

Bachelor's degree and 8 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

And

2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.hrive

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.

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