Manager Quality Control Support - Digital Laboratory Systems

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.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing 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.

Manager Quality Control Support - Digital Laboratory Systems

What you will do

Let’s do this. Let’s change the world. In this vital role you will In this vital role, Amgen is seeking a Quality Control Manager to lead and manage QC laboratory digital systems including LIMS (Laboratory Information Management System), CIMS (Content Information Management System), LMES (Laboratory Method Execution System), and Empower. This role ensures the initial build, availability, compliance, and continuous improvement of QC lab systems to support the release and stability testing of commercial and clinical drug products. The Manager will serve as the manager, technical lead and business owner liaison for QC digital platforms, driving data integrity, system performance, and operational excellence.

Under minimal supervision, the successful candidate will support the startup of the QC organization by:

System Ownership & Compliance

• Manage team of QC business system owners and SME’s for LIMS, CIMS, LMES, and Empower.
• Ensure systems built, validated, maintained, and operated in compliance with regulatory and internal data integrity requirements.
• Partner with IS, Quality Assurance, and global counterparts for lifecycle management and audits/inspections support.
• Author/review system-related documentation (URS, configuration specs, validation protocols, change controls).

Operational Support & Continuous Improvement

• Oversee day-to-day support for QC system users; manage issue resolution and user access control.
• Coordinate enhancements, upgrades, and integrations of digital systems within the QC organization.
• Support method configuration, template design, report generation, and master data management in collaboration with laboratory leads.
• Drive automation, standardization, and lean improvements in QC digital workflows.

Cross-functional Collaboration & Leadership

• Work cross-functionally with Manufacturing, Analytical Sciences, IT, and Quality teams to align systems with business needs.
• Represent QC in digital governance forums and global harmonization initiatives.
• Lead or support system projects related to new product introductions, new lab capabilities, and system upgrades.
• Train QC staff on system use and best practices; establish SOPs and training materials as needed.

What we expect of you

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

Basic Qualifications:

• High School/GED 12 years of Quality work experience OR
• Associate’s 10 years of Quality work experience OR
• Bachelor’s 5 years of Quality work experience OR
• Master's 3 years of Quality work experience OR
• Doctorate degree

Preferred Qualifications:

• Master’s degree or certification in Information Systems, Laboratory Informatics, or Quality Management
• Hands on Quality Control Laboratory experience
• Hands-on experience administering or configuring LIMS (e.g., Samp