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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

Does the thought of building an entirely new site from the ground up excite you? Do you love cultivating sustainable systems and 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.

Amgen, one of the world’s leading biotechnology companies is investing $550 million to build a new multi-product drug substance bio-manufacturing facility in Holly Springs, North Carolina, a bio-manufacturing “hub” known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls “FleX Batch” manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgen’s plan to be carbon neutral by 2027.

The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities and office space. Amgen is targeting 2024 for site completion.

Let’s do this. Let’s change the world. The Senior Manager QA is a vital role for ensuring quality and compliance are built into the new Amgen North Carolina (ANC) facility from the start, with varied and dynamic responsibilities. You will lead activities associated with quality oversight of the design, installation, commissioning & qualification and process qualification of the new facility and equipment. You will collaborate cross-functionally through all stages (construction, facility start-up, operational readiness, operations) to ensure project timelines and landmarks are met. You will lend quality expertise and guidance to strategic and tactical decisions, ensuring both efficiency and compliance in business and operational processes. The Senior Manager QA will also support the Quality Site Head in building out the quality organization and implementing the Amgen Quality Management System for the new facility. As the ANC Quality organization expands and the site becomes operational, the Senior Manager QA role will then evolve and focus in on a specific area, such as quality systems, quality technical support, or oversight of operations.

Responsibilities:

• Ensure the design of the facilities and equipment, materials, organization, processes, procedures and products stay in sync with cGMP requirements and other applicable regulations.
• Provide quality and compliance expertise and agree on execution strategies related to the design, installation, commissioning & qualification and process qualification of the new facility, equipment, and information systems.
• Directly support and provide leadership for quality review and approval of documents to support facility commissioning and qualification, according to project timelines.
• Ensure the Quality unit provides review, approval and tracking of cGMP processes, procedures, protocols, assays, documents and records including but not limited to deviations, CAPA's, and Change Controls.
• Ensures that all activities & related documentation for facilities, equipment, materials and processes align with applicable regulations and Amgen requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and Controls.
• Identify and drive implementation of continuous improvement opportunities.
• Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and carried out in accordance with established procedures and applicable regulations.
• Build and manage a strong team of Quality professionals that will partner effectively and provide quality oversight for the new facility in the future.
• Ensures deviations from established procedures are investigated and documented per procedures
• Represent the quality unit during audits and inspections as needed.

Win

What we expect of you

Basic Qualifications:

Doctorate degree and 2 years of Quality experience

Master’s degree and 6 years of Quality experience

Bachelor’s degree and 8 years of Quality experience

Associate degree and 10 years of Quality experience

Or

High school diploma / GED and 12 years Quality experience

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

We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic, flexible and driven individual with these qualifications.

Required Skills

• 2+ years of management experience at a senior quality level.
• Experience in (or strong understanding of) biologics drug substance operations.
• Strong understanding of regulatory requirements and trends, and industry standards.
• Ability to provide sound quality guidance and make data-driven, risk-based, decisions.
• Excellent written and verbal communication skills, with ability to communicate effectively with all levels in the organization.
• Strong leadership capabilities, including ability to develop, coach, empower, and retain staff.
• Ability to effectively collaborate and partner to solve problems, drive improvement, and meet site goals.

Preferred Skills

• Previous experience in quality oversight of commissioning, qualification, and validation.

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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