Senior Manager Quality Control Support - BioSpace : Job Details

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Join Amgens Mission of Serving PatientsAt Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.Amgen, one of the worlds leading biotechnology companies, is investing $550 million to build a new multi-product drug substance bio manufacturing facility in Holly Springs, North Carolina, a bio manufacturing hub known for their life sciences industry. The new plant will combine two production formats, traditional stainless-steel fed-batch and single-use technology. This combination of capabilities is an approach that Amgen calls FleX Batch manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgens plan to be carbon neutral by 2027.The investment will bring approximately 355 jobs comprised of highly skilled workers that will be built on a foundation that promotes diversity, inclusion and belonging. The site will include the manufacturing plant, warehouse, central utilities and office space. Amgen is targeting 2024 for site completion.Senior Manager Quality Control SupportWhat You Will DoLets do this. Lets 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 Amgens 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 at all times.
• 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.

What We Expect Of YouWe 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.Basic 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

AndIn addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced abovePreferred Qualifications

• 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

What You Can Expect Of UsAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, well support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now and make a lasting impact with the Amgen team.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.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 that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Seniority level

• Seniority levelMid-Senior level

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesInternet News

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