Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

Does the thought of building an entirely new site, from the ground up excite you?  Do you love building and developing high performing teams?  If you have a passion for talent development and want to be a part of Amgen’s mission to serve patients – every patient every time – then check out this exciting new opportunity.

Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the Advanced Assembly and Final Product Operation facility will not only feature the best in-class assembly and packaging technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen’s plan to be a carbon-neutral company by 2027.

If you feel like you are 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 (IQA-WHS-DIS)

Reporting to the Quality Site Head, the Senior Manager Quality for the new Amgen Advanced Assembly and Final Product Operation facility will effectively manage the daily work of direct reports responsible for the setup of Incoming Quality activities (receipt of packaging materials and unlabeled drug product) and the quality oversight of the design, installation, commissioning & qualification and process qualification of the new facility and equipment with a focus on the warehouse (WHS), including a fully automated Storage and Retrieval System (ASRS) and Automated Guided Vehicles (AGVs). When the facility is licensed and ready to assemble, label and package commercial drug product, the Senior Manager Quality (IQA-WHS-DIS) and team will be responsible for all incoming quality activities and provide quality oversight for all activities related to warehousing (inbound & outbound) and distribution (DIS). The Senior Manager QA will be part of the Quality Leadership team of the facility and will provide support to build out the quality organization and implement the Amgen Quality Management System.

Live

What you will do

Let’s do this. Let’s change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery, and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.

In this vital role you will lead a team of Quality professionals supporting the set-up of a new facility. This is a unique role and combines the aspects of supporting the set-up of a new facility and equipment from a quality perspective and building out a new quality organization that will effectively support the facility in the future. Eventually the role will hold responsibilities related to Incoming Quality and Quality oversight for warehousing and distribution activities.      

Key Responsibilities:

• Ensure the design of the facilities and equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.

• Ensure the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records including but not limited to deviations, CAPAs, Change Controls and validation documentation.

• Ensure relevant processes, equipment, system and assays are validated and the validation is current.

• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and executed in accordance with established procedures and applicable regulations. Partner with other sites in the network to ensure implementation of best practices, consistency and continuous improvement.

• Build and manage a strong team of Quality professionals that will provide quality oversight for all warehouse related activities, including distribution and the incoming Quality team.   

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

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

• Keep up to date with emerging trends and regulatory advances in the areas of Incoming Materials, warehouse and distribution activities and ensure appropriate staff development and training in areas of responsibility.

• Champion Continuous Improvement initiatives, programs, and projects.

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

• Alert senior management of significant quality, compliance, supply, and safety risks, often requiring the coordination of activity across organizational units. Exercise judgement independently.

• Drive efficient data management and digital innovation within department.

• Represent the quality unit during audits and inspections as needed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic leader with the following 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

Highschool 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

Beyond that, additional preferred qualifications are:

• 2+ years of Management at a senior quality level

• Experience in finished drug product manufacturing, warehousing, and distribution activities

• Experience interacting with multiple sites

• Working/detailed knowledge of GMPs and global QA requirements as related to GMP manufacturing in US and multiple jurisdictions

• Affinity for digital innovation and data analytics

• Experience with lean principles

• 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 QMTS, CDOCS, SAP, LIMS etc.

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

• 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.

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