Senior Manager Quality Control Support

Amgen

About The Position

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. Senior Manager Quality Control Support What you will do Let’s do this. Let’s change the world. In this vital role, 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.

Requirements

High school diploma / GED and 12 years of Quality Analytical testing experience OR Associate’s degree and 10 years of Quality Analytical testing experience OR Bachelor’s degree and 8 years of Quality Analytical testing experience OR Master’s degree and 6 years of Quality Analytical testing experience OR 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 Haves

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

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.