Manager Quality Control Support - Digital Laboratory Systems

Company: Amgen
Location: Holly Springs
Posted on: July 12, 2025

Job Description:

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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 Lets do this. Lets 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 SMEs 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 Associates 10 years of Quality work experience OR Bachelors 5 years of Quality work experience OR Master's 3 years of Quality work experience OR Doctorate degree Preferred Qualifications: Masters 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., SampleManager), Empower, LMES , and/or CIMS Familiarity with GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA principles Demonstrated project management experience with system implementations or upgrades Excellent communication, analytical, and leadership skills 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. In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans and an annual site shutdown Flexible work models, including remote work arrangements, where possible Apply now and make a lasting impact with the Amgen team. careers.amgen.com In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Keywords: Amgen, Cary , Manager Quality Control Support - Digital Laboratory Systems, Engineering , Holly Springs, North Carolina