Senior Manager Quality Control

Overview

Join Amgen's mission of serving patients. At Amgen, our work is driven by a shared mission to serve patients living with serious illnesses. Since 1980, we have helped pioneer biotech in the fight against the world's toughest diseases, with focus areas in Oncology, Inflammation, General Medicine, and Rare Disease. We aim to research, manufacture, and deliver innovative medicines to help people live longer, fuller lives.

Our culture is collaborative, innovative, and science-based, encouraging challenges and career growth.

Be part of Amgen's newest and most advanced drug substance manufacturing plant. The FleX Batch facility will combine disposable technologies with traditional stainless-steel equipment to maximize flexibility, integrate industry 4.0 capabilities, and drive sustainability to support Amgen's plan to be carbon-neutral by 2027.

Senior Manager
Quality
Control
Support

Let’s do this. In this vital role, Amgen seeks a Senior Manager of Quality Control Support for our state-of-the-art manufacturing facility in Holly Springs, North Carolina. The leader will oversee 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.

• Strategic Leadership – 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.
• Quality Systems and Compliance – Ensure QC operations maintain inspection readiness; own and oversee laboratory deviation investigations, CAPA management, change control, and document lifecycle.
• Operational Support and Optimization – 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.
• Talent Development and Cross-functional Engagement – 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.

We are all different, yet we all use our unique contributions to serve patients. The Senior Manager Quality Control Support we seek is a dynamic, resilient, flexible, and driven individual with these qualifications.

• High school diploma / GED and 12 years of Quality Analytical testing experience OR
• Associates degree and 10 years of Quality Analytical testing experience OR
• Bachelors degree and 8 years of Quality Analytical testing experience OR
• Masters degree and 6 years of Quality Analytical testing experience OR
• Doctorate degree and 2 years of Quality Analytical testing experience

And 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.

• Masters 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

As we work to develop treatments that take care of others, we also support your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive Total Rewards Plans aligned with local industry standards. Apply now and make a lasting impact with the Amgen team.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure reasonable accommodation for individuals with disabilities to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment.

Please contact us to request accommodation.