Amgen

Sr. Manager QA

Employer
Amgen
Location
Columbus, OH
Posted
Oct 09, 2021
Ref
R-126500
Required Education
Associate Degree
Position Type
Full time

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 / Digital Quality Lead for the new Amgen Advanced Assembly and Final Product Operation facility will provide Quality oversight of the development and implementation of the digital advancement opportunities for the new facility and will lead the development of the digital Quality strategy for the new facility and oversee effective implementation of that strategy. 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 with a dedicated focus on ensuring the digital advancement is considered.

This role will require local presence at the New Albany facility near Columbus, Ohio.

Live

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 be responsible for leading and directing cross functional staff to advance the digital Manufacturing and Quality innovation activities in combination with the support required for the set-up of a new facility and equipment. This is a unique role and combines the aspects building out a new quality organization that will effectively support the facility in the future while advancing digital innovation in a state-of-the-art manufacturing facility.

Key Responsibilities:

  • Provide quality oversight of the development and execution of the digital manufacturing strategies for the new facility

  • Identify digital advancement opportunities for quality and lead their implementation into the new facility while ensuring Quality Processes are adhered to or adjusted as appropriate

  • Collaborate cross functionally and across the Amgen Enterprise/Network to ensure digital advancement is executed in accordance with established procedures and applicable regulations. Partner with other facilities in the network to ensure implementation of best practices, consistency and continuous improvement.

  • 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.

  • Build and manage a team of Quality professionals

  • Ensures deviations from established procedures are investigated and documented per procedures

  • Represent the quality unit during audits and inspections as needed

Win

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.

Basic Qualifications:

Doctorate degree and 2 years of Quality experience

Or

Masters degree and 6 years of Quality experience

Or

Bachelors degree and 8 years of Quality experience

Or

Associates degree and 10 years of Quality experience

And

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

  • Affinity with digital innovation, data sciences and Quality engineering

  • IS validation knowledge; system experience with MES, SCADA, IDA etc.

  • 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

Thrive

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.

careers.amgen.com

#Operations21Equal 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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff


Join Us

If 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.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.