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!

Responsibilities

The role of the GCP/GLP Compliance Manager is to support the provision of proactive GCP/GLP compliance oversight and guidance to functional areas and partner groups within the R&D organization.

• Providing objective compliance advice and oversight, strengthening and advancing the organization’s Quality Management System (QMS) and improving processes through identifying and completing appropriate CAPAs

• Supporting RCA and effectiveness verification activities of CAPAs.

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

• Assessing and managing quality and accuracy of data in R&D CAPA System and providing related compliance reporting and metrics.

• Supporting GCP/GLP inspection readiness and management.

• Supporting GCP/GLP Compliance on governance bodies in the clinical development area.

• Supporting functional activities including deviation management, inspection readiness and administration of compliance committee.

• Maintaining knowledge of current regulatory, CAPA and compliance practices/issues.

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

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 compliance experience

Experience

• Minimum 4 years in biopharmaceutical industry

• Minimum 2 years in GxP compliance

• Experience in deviation management (include RCA) in a GxP setting

• Experience supporting regulatory authority inspections of GxP (e.g.clinical research, pharmacovigilance) activities

• Participation in process improvement initiatives

Knowledge

• Knowledge of global GxP regulations

• Knowledge of regulatory authority inspection processes

• General knowledge GxP processes and operations in the bio-pharmaceutical industry

• Understanding of audit/compliance program design

Preferred Requirements

• GxP Quality Assurance Qualification/Certification (recommended)

Competencies

• Disciplinary knowledge; demonstrate discernment and subject matter expertise

• Understanding of company goals and competitor practices

• Understanding of company business priorities, strategy and direction

• Knowledge of areas addressed by the GxP Compliance function

• Knowledge of R&D function and business principles

• Applies analytical skills to evaluate and interpret compliance situations (and viable solutions) using multiple sources of information, including qualitative, quantitative and trend data

• Manages multiple assignments

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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