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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 Quality Assurance

Live

What you will do

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

• Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.

• Ensures that facilities, equipment, materials, organization, processes, procedures and products align with cGMP practices and other applicable regulations.

• Responsible for Quality disposition (approval or rejection) of raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas.

• Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformances, CAPAs, and validations.

• Supports Continual Improvement initiatives, programs and projects.

• Ensures that changes that could potentially impact product quality are assessed according to procedures.

• Ensures that deviations from established procedures are investigated and documented per procedures.

• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

• Ensures that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.

• Collaborates cross functionally and across the Amgen Enterprise/Network to ensures the Quality Management System processes are implemented, maintained and performed in accordance with established procedures and applicable regulations.

• Alerts senior management of significant quality, compliance, supply and safety risks.

• Represents the quality unit during audits and inspections as needed.

• Supports internal/external audits and inspections as part of the audit/inspection management team as needed.

• Completes required assigned training to permit execution of required tasks.

• Performs additional duties as specified by management.

Win

What we expect of you

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

Basic Qualifications:

• Doctorate degree and 2 years of Quality experience OR

• Master’s degree and 6 years of Quality experience OR

• Bachelor’s degree and 8 years of Quality experience OR

• Associate’s degree and 10 years of Quality experience OR

• High school diploma / GED and 12 years of Quality experience 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:

• 5+ years of Quality experience, with at least 2 years of direct Disposition experience.

• Experience with the review and Disposition of batches for all phases of drug development.

• Experience interacting with multiple sites and QPs.

• Solid understanding of GMPs and global QA requirements as related to lot Disposition to US and multiple jurisdictions.

• Understanding of the Disposition Process’ integration with and relationship to other Quality Processes.

• Previous managerial experience.

• Proven leadership and organizational skills.

• Skilled in technical writing and critical thinking.

• Computer Skills: Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe Acrobat; database related platforms; knowledge of Electronic Document Management System (EDMS).

• Good organizational, communication and presentation skills, effective project and time management skills, and be able to work well under pressure.

• Highly organized and possess excellent attention to detail.

• Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment.

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.

careers.amgen.com