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Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.

Quality Assurance (QA) Director – Aseptic Processing Global Lead

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will primarily provide direct support for Quality Science deliverables as they relate to:

• Leading the Aseptic Processing Council and serve as an Aseptic Processing SME

• Advancing Amgen’s aseptic processing standards and procedures and ensure compliance with changing regulatory requirements

• Developing training and qualification materials for aseptic processing staff

As a QA Director you will:

• Provide decision on what post-marketing events must be called out for reportability evaluations (Biological Process Deviation/Field Alert Reporting) to be in overall compliance with reporting regulations in the U.S.

• Acts as GMP Compliance Subject-Matter Expert (SME), for complaint investigations, manufacturing deviations, global inspection responses and other regulatory communications

• May lead cross-functional regulatory response teams in support of Amgen deadlines

• Provide recommendations for compliance improvement of Amgen systems and processes

• Review internal procedures and evaluate if they meet current regulatory guidance and expectations

• Assure needed technical content is available to support rationale provided in deviations and complaint investigations

• Review remediation plans for compliance with Quality Improvement plans and current regulations

• Assist with generation of inspection playbooks and ensure staff are prepared to present during regulatory inspections

• Ability to travel +/- 20% of time to domestic and international Amgen sites

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 subject-matter expert with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of Quality Science or Manufacturing experience

OR

Master’s degree and 8 years of Quality Science or Manufacturing experience

OR

Bachelor’s degree and 10 years of Quality Science or Manufacturing experience

Preferred Qualifications:

• Over 10 years’ experience as PQA, Manufacturing, PD or Aseptic Processing Validation (Real time at the floor, no education equivalence)

• Aseptic Processing investigations as an owner or as Quality

• Demonstrated experience in a Fill and Finish (Biological Drug Product) facility preferably in a Plant Quality Assurance position

• Ideally, experience with barrier technology such as RABS and isolators.

• Understanding of decontamination, sanitization, sterilization and lyophilization principles

• Proficient in qualification and experience working with the design requirements for aseptic processing facilities

• Experience working with regulatory agencies specifically during inspections

• Ability to lead cross-functional teams, consistent timely and high-quality results

• Collaborates and communicates exceptionally well with a broad group of partners across functions

• Maintains integrity even in the face of conflict

• Ability to operate in a matrixed or team environment with site, functional, and executive leadership

• Understanding of Quality Management Systems (QMS), industry requirements/expectations of a QMS and device regulations

• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)

• Able to successfully manage workload to timelines; ability to oversee multiple projects simultaneously

• Familiarity with basic project management tools

• Ability to travel +/- 20% of time to domestic and international Amgen sites

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.

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