Senior Manager Quality Assurance

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 Assurance

What you will do

Lets do this! Lets change the world!

• Lead a team of Quality professionals evaluating and providing a disposition decision (approval or rejection) for manufactured batches of drug substance, filled drug product, and finished drug product for assigned areas.

• Collaborate cross functionally and across the Amgen network serving as Site Disposition Process Owner to ensure the Disposition process is implemented, maintained and performed at the Thousand Oaks site in accordance with established procedures and applicable regulations.

• Verify that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.

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

• Verify that deviations from established procedures are investigated and documented per procedure.

• Provide Quality oversight to ensure that clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.

• Perform review, approval and tracking of cGMP processes, procedures, assays, documents and records.

• Support Continuous Improvement initiatives.

• Serve as Site Process Owner for one or more additional Quality Processes as needed.

• Alert senior management of significant quality, compliance, supply and safety risks.

• Represent the quality unit during audits and inspections as needed.

• Support internal/external audits and inspections as part of an audit/inspection management team as needed.

• Complete required assigned training to permit execution of required tasks.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.

• Doctorate degree and 2 years of Quality or Manufacturing experience OR

• Masters degree and 6 years of Quality or Manufacturing experience OR

• Bachelors degree and 8 years of Quality or Manufacturing experience OR

• Associates degree and 10 years of Quality or Manufacturing experience OR

• High school diploma / GED and 12 years of Quality or Manufacturing experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

• 5+ years of Quality experience, with at least 2 years of direct Disposition experience.

• Experience with the review and Disposition of batches for all phases of drug development.

• Experience interacting with multiple sites and global cGMP requirements.

• Solid understanding of cGMPs and global QA requirements as related to lot Disposition to US and multiple jurisdictions.

• Understanding of Disposition Process integration with and relationship to other Quality Processes.

• Previous management experience.

• Proven leadership and organizational skills.

• Strong technical writing and critical thinking skills.

• Computer Skills: Microsoft Excel, Word, Power Point, Project, and Visio; Adobe Acrobat; database related platforms; knowledge of Electronic Document Management System (EDMS).

• Good organizational, communication and presentation skills, effective project and time management skills, and ability to work well under pressure.

• Excellent attention to detail.

• Self-motivation and ability 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, we also work to care for our teammates professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

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 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.