Quality Compliance Manager

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

QUALITY COMPLIANCE MANAGER

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide quality support for the development and implementation of a risk-based quality assurance strategy for all stages of products in non-clinical development, with the main focus of maintaining the integrity of Amgen's research data. You will be covering both regulated and non-regulated research, including Good Laboratory Practice (GLP).

• Support GLP compliance oversight through cross-functional collaboration with functional areas and customer groups within Research in alignment with standard practices

• Plan, conduct and report out on risk-based R&D audits. Review, negotiate and approve responses to R&D audit findings and provide oversight for compliance activities through to finding closure

• Manage deliverables and provide data and recommendations regarding the state of quality for processes, technology, laboratory and external vendor performance

• Support the establishment of regional expertise to ensure quality and compliance to local regulations as well as support research-specific data integrity, including technologies for data collection and measurement

• Support Research for all quality management activities, including Deviations/CAPAs, Inspection Readiness and Management, compliance related questions and critical issues

• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods)

What we expect of you

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

Basic Qualifications:

• Doctorate degree OR

• Master’s degree and 2 years of Quality/Compliance/Process Management experience OR

• Bachelor’s degree and 4 years of Quality/Compliance/Process Management experience OR

• Associate’s degree and 8 years of Quality/Compliance/Process Management experience Or

• High school diploma / GED and 10 years of Quality/Compliance/Process Management experience

Preferred Qualifications:

• Experience in Quality Management, Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility

• Experience with Quality Oversight of Nonclinical Trials, including auditing GLP phases, data and final reports, as well as partnership with third-party vendors, suppliers and partners

• Oversight of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Track wise

• Detailed understanding of R&D activities and Global Regulations

• Knowledge of the Regulatory Submission and Inspection Management procedures

• Excellent verbal and written communication skills, including significant business writing abilities and active listening

• Ability to transform business and team member feedback into clear, efficient processes using a straightforward language and format

• Strong analytical, critical-thinking and decision-making abilities

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto