Career Category

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.

Process Optimization Manager

Live

What you will do

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

Description

Responsible identify plan and implement process improvement opportunities in the Digital Health and Diagnostics quality organization demonstrating lean business systems tools and processes. Manage External audit and inspection preparations and follow up Reponses.

Key Responsibilities

• Employ quality principles and company’s procedures including but not limited to the areas of good software engineering, medical device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, and Product Complaints & Surveillance.

• Identify plan and complete process improvement opportunities to the quality system

• External audit and inspection prep, conduct and follow up

• Lead cross-functional investigation teams in order to identify concrete root causes and robust corrective and preventative actions by effectively applying advanced root cause analysis tools

• Work in partnership with DH&DQ Leadership to forge consensus among challenging client interests while ensuring objectives are met

• Coordinate and oversee all process changes

• Skilled in Lean and Six Sigma techniques, visual management

• Knowledge in Supply chain and distribution processes

• Review procedures and work instruction

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 Quality, Engineering or Operations experience in the pharmaceutical and/or medical device industry

Or

Master’s degree and 6 years of Quality, Engineering or Operations experience in the pharmaceutical and/or medical device industry

Or

Bachelor’s degree and 8 years of Quality, Engineering or Operations experience in the pharmaceutical and/or medical device industry

Or

Associate’s degree and 10 years of Quality, Engineering or Operations experience in the pharmaceutical and/or medical device industry

Or

High school diploma / GED and 12 years of Quality, Engineering or Operations experience in the pharmaceutical and/or medical device industry Bachelors degree in Life sciences, Engineering, software, medical devises, IS.

And

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

Preferred Qualifications:

• Root Cause Analysis Tools. E.g.- Causal Factor Analysis, Fault Tree Analysis, Kepner-Tregoe, etc.)

• Experience with Quality Management Systems and related standards and regulations

• Excellent Written, verbal and presentation communication skills

• Proficient with MS word, PowerPoint, Excel and Visio

• Proficient with Track Wise, Veeva Vault and other professional tools

• Bachelors degree in Life sciences, Engineering, IS, or related subject area

• 5 years of professional experience in Program Management, Operational Excellence, Quality, R&D, or Production

• Strong project management skills / ability to lead and/or lead all aspects of multiple projects simultaneously

• General knowledge of cGxP regulations, practices, and trends pertaining to medical device quality

• Demonstrated strong leadership, negotiation and influencing skills along with advanced communication and analytical skills

• Effective and timely decision making and influencing skills

• Executive management communication experience

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