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Amgen is seeking a Senior Manager of Quality Control Support for our state-of-the-art manufacturing facility in Holly Springs, North Carolina. This leader will be responsible for overseeing key support functions within the QC organization, including laboratory systems, compliance, document management, sample lifecycle coordination, and continuous improvement initiatives. The role ensures alignment with cGMP standards, regulatory expectations, and Amgen’s global quality systems.
Job Responsibility:
Lead and develop a high-performing QC support team with expertise in lab operations, documentation, and compliance systems
Drive alignment between site QC operations and global Amgen quality policies and procedures
Ensure QC operations maintain inspection readiness at all times
Own and oversee laboratory deviation investigations, CAPA management, change control, and document lifecycle
Oversee implementation and maintenance of LIMS, Empower, and other QC systems
Manage QC scheduling, sample logistics, and coordination with internal/external stakeholders
Lead and support digital and lean initiatives to improve lab efficiency, throughput, and compliance
Recruit, mentor, and develop team members to build a robust talent pipeline
Partner with Quality Assurance, Analytical Sciences, Manufacturing, and Regulatory to ensure seamless quality operations
Requirements:
High school diploma / GED and 12 years of Quality Analytical testing experience
Associate’s degree and 10 years of Quality Analytical testing experience
Bachelor’s degree and 8 years of Quality Analytical testing experience
Master’s degree and 6 years of Quality Analytical testing experience
Doctorate degree and 2 years of Quality Analytical testing experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Nice to have:
Master’s degree or higher in a scientific or quality-related discipline
Experience in new facility start-up or tech transfer projects
Expertise in global regulatory requirements (FDA, EMA, etc.)
Strong background in laboratory compliance, LIMS, LMES, CIMS, Veeva and Trackwise systems
Lean Six Sigma or continuous improvement certification
Exceptional communication, leadership, and problem-solving skills
2+ years of management experience at a senior level
Strong Leadership, Collaboration and Communication skills
What we offer:
competitive and comprehensive Total Rewards Plans that are aligned with local industry standards