Senior Manager Quality Control Support

Role Summary

Senior Manager, Quality Control Support at Amgen's Holly Springs, North Carolina manufacturing facility. Oversees key QC support functions including laboratory systems, compliance, document management, sample lifecycle coordination, and continuous improvement initiatives, ensuring alignment with cGMP standards, regulatory expectations, and Amgen’s global quality systems.

Responsibilities

• 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.

Qualifications

• Required: High school diploma / GED and 12 years of Quality Analytical testing experience; OR Associate’s degree and 10 years; OR Bachelor’s degree and 8 years; OR Master’s degree and 6 years; OR Doctorate degree and 2 years.
• Required: 2 years of managerial experience directly managing people and/or leading teams, projects, programs, or resource allocation.
• Preferred: Master’s degree or higher in a scientific or quality-related discipline.
• Preferred: Experience in new facility start-up or tech transfer projects.
• Preferred: Expertise in global regulatory requirements (FDA, EMA, etc.).
• Preferred: Strong background in laboratory compliance, LIMS, LMES, CIMS, Veeva and Trackwise systems.
• Preferred: Lean Six Sigma or continuous improvement certification.
• Preferred: Exceptional communication, leadership, and problem-solving skills.
• Preferred: 2+ years of management experience at a senior level.