Senior Manager Quality Control Support
Senior Manager Quality Control Support
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$ 176758 - 176758
1 Vacancy
Job Description
Career Category
QualityJob Description
Join Amgens Mission of Serving Patients
At 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 Support
What you will do
Lets 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 you
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.
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
And
In 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 above
Preferred 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 us
As 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.
As 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.
.Salary Range
145470.00 USD - 176758.00 USDRequired Experience:
Senior Manager
Employment Type
Full-Time
