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Sr. Manager QA (Quality Systems/Technical QA)

Employer
Amgen
Location
New Albany, OH
Start date
Nov 13, 2022

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Job Details

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre 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.

Senior Manager Quality (Quality Systems/Technical QA)

Live

What you will do

Lets do this. Lets change the world. In this role you will lead a team of Quality professionals supporting the set-up of a new facility. This is a unique role and combines the aspects of supporting the set-up of a new facility, implementing the Amgen Quality Management system and building out a new quality organization that will effectively support the facility in the future.

  • Manage, lead and motivate a strong team of Quality professionals responsible for technical quality (Quality Engineering, QA Validation, QA support for larger projects and New Product Introductions) and Quality Systems (Document Management; Training; Compliance; Internal Audit Program, Management Review etc.)

  • Ensure staff is qualified and trained to perform assigned functions in accordance with cGMP requirements

  • Manage workload and resource distribution

  • Manage budget forecast, planning & monitoring

  • Develop, maintain and implement inspection readiness program for the new facility in preparation of regulatory inspections

  • Ensure the Quality Management System at AOH is continuously improved and in compliance with Amgen Standards, cGMP practices and other applicable regulations.

  • Set up and lead Management Review process for the new Amgen facility (lead meetings, maintain metric control program etc.)

  • 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, and systems are validated and the validation is current.

  • Quality Systems lead role for the new Amgen facility; collaborate cross functionally and across the Amgen Enterprise/Network to ensure the Quality Management System processes are implemented, maintained and completed in accordance with established procedures and applicable regulations. Partner with other sites in the network to ensure implementation of standard processes, consistency and continuous improvement.

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

  • Ensure that changes that could potentially impact product quality are assessed according to procedures.

  • Keep up to date with emerging trends and regulatory advances in the areas of responsibility

  • Champion Continuous Improvement initiatives, programs, and projects.

  • Own Amgen Ohio Internal Audit program; ensure that GMP functions are periodically audited to assess compliance to cGMP regulations and to identify potential risks.

  • Alert senior management of significant quality, compliance, supply, and safety risks, often requiring the coordination of activity across organizational units. Exercise judgement independently.

  • Drive efficient data management and digital innovation within department.

  • Represent the quality unit during audits and inspections as needed

  • Responsible for hiring, succession planning and performance management of staff

  • Collaborate with industry leaders to guide the implementation of new regulatory guidance / requirements.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The outstanding professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Quality experience

Or

Master's degree and 6 years of Quality experience

Or

Bachelor's degree and 8 years of Quality experience

Or

Associate's degree and 10 years of Quality experience

Or

Highschool diploma / GED and 12 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.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also 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
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.

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.

Amgen requires all staff in the United States, Puerto Rico and Canada 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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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