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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.

This is an exciting opportunity for a Compliance Senior Manager (Auditor) position within Amgen's Global Quality Compliance, R&D Audit team. It is a key Quality Assurance role in the Global Quality Compliance organization, with primary responsibility for planning and participating in global GCP and/or PV audits. The breadth of audits performed include audits of Amgen’s clinical trials, vendors, internal processes and pharmacovigilance activities. This position can be based at Amgen's corporate headquarters in Thousand Oaks, California or remote. However, the preference is that the role be based in Thousand Oaks, CA. The position requires approximately 30% travel to US and international audit sites ( when travel restrictions lift).

• Plan, conduct and report routine and directed clinical trial, GLP and PV compliance audits

• Follow-up on audit responses until acceptable corrective actions are agreed

• Identify and communicate compliance risks to GQC management

• Host and/or play a lead role in regulatory authority inspections as required

• Lead GQC process improvement initiatives

• Author and contribute to the development of GQC cross functional controlled documents

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.

Basic Qualifications:

• Doctorate degree & 2 years of Regulatory & Compliance experience OR

• Master’s degree & 6 years of Regulatory & Compliance experience OR

• Bachelor’s degree or & 8 years of Regulatory & Compliance experience OR

• Associate’s degree & 10 years of Regulatory & Compliance experience OR

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

Preferred Qualifications:

• Bachelor’s degree in appropriate discipline or equivalent experience

• 5+ years auditing experience in GCP and/or PV auditing experience a plus

• Experience supporting regulatory authority inspections

• International auditing experience

• Participation in process improvement initiatives knowledge

• Knowledge of regulations applicable to area of technical expertise

• General knowledge of clinical development and PV process and operations

• Knowledge of audit/compliance program design and audit methodology

• Knowledge of GLP/PV and GCP Key Competencies

• Team work

• Motivation skills

• Leadership skills

• Verbal and written communication

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

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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