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Senior Manager Quality Control Support

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Amgen

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Location:
United States , Holly Springs

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Category:
-

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Contract Type:
Not provided

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Salary:

151584.00 - 182019.00 USD / Year

Job Description:

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

Additional Information:

Job Posted:
January 16, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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