Sr. Manager QA
HOW MIGHT YOU DEFY IMAGINATION?
Does the thought of building an entirely new site, from the ground up excite you? Do you love building and developing high performing teams? If you have a passion for talent development and want to be a part of Amgens mission to serve patients every patient every time then check out this exciting new opportunity.
Be part of the Amgen Advanced Assembly and Final Product Operation, a new facility focused on medical device assembly and packaging of injectable medicines. When completed, the Advanced Assembly and Final Product Operation facility will not only feature the best in-class assembly and packaging technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgens plan to be a carbon-neutral company by 2027.
If you feel like you are part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us.
SENIOR MANAGER QUALITY
Reporting to the Quality Site Head, the Senior Manager Quality for the new Amgen Advanced Assembly and Final Product Operation facility will effectively manage the daily work of direct reports responsible for the quality oversight of the design, installation, commissioning & qualification and process qualification of the new facility and equipment. The Senior Manager QA will also support the Quality Site Head in building out the quality organization and implementing the Amgen Quality Management System for the new facility.
The final location of this role is yet to be determined candidates must be open to relocating within Continental USLive
What you will do
Lets do this. Lets change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps fuel scientific innovation and problem solving, leading to better scientific solutions that benefit both patients and society.
In this vital role you will lead a team of Quality professionals supporting the set-up of a new facility and equipment. This is a unique role and combines the aspects of supporting the technical set up of a new facility and equipment from a quality perspective and building out a new quality organization that will effectively support the facility in the future.
Ensure the design of the facilities and equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
Ensure the Quality unit provides review, approval and tracking of cGMP processes, procedures, assays, documents and records including but not limited to deviations, CAPAs, Change Controls and validation documentation.
Ensure relevant processes, equipment, system and assays are validated and the validation is current.
Collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and executed in accordance with established procedures and applicable regulations. Partner with other packaging sites in the network to ensure implementation of best practices, consistency and continuous improvement.
Build and manage a strong team of Quality professionals that will provide quality oversight for the new facility in the future.
Ensures deviations from established procedures are investigated and documented per procedures
Represent the quality unit during audits and inspections as needed
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Quality professional we seek is a dynamic leader with the following qualifications.
Doctorate degree and 2 years of Quality experience
Masters degree and 6 years of Quality experience
Bachelors degree and 8 years of Quality experience
Associates degree and 10 years of Quality experience
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Beyond that, additional preferred qualifications are:
2+ years of Management at a senior quality level
Experience in finished drug product manufacturing activities
Experience interacting with multiple sites
Working/detailed knowledge of GMPs and global QA requirements as related to GMP manufacturing in US and multiple jurisdictions
Proven leadership and organizational skills
Skilled in technical writing and critical thinking
Computer Skills: Microsoft Excel, Word, Power Point, Project, Access, and Visio; Adobe
Acrobat; database related platforms; knowledge of QMTS, CDOCS, SAP, LIMS etc.
Good organizational, communication and presentation skills, effective project and time management skills, and ability to work well under pressure.
Excellent attention to detail
Motivated, self-directed, able to work autonomously and have a proven ability to work in a team environment
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
Equal Opportunity Statement
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided a 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 an accommodation.
Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.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, or disability status.