27 days old

Executive Director Quality, Global External Supply

Amgen
Thousand Oaks, CA 91360
  • Job Code
    119995471
Amgen

Job ID: R-98837
Location: Thousand Oaks, CA, US 91360

Job Summary

This role will oversee a global team of quality professionals with responsibility for quality oversight of external suppliers which provide global goods and services to Amgen. This includes Contract Manufacturing Organizations (CMOs), contract labs that provide regulated testing, device manufacturers and material suppliers that provide product contact materials to Amgen sites. Part of a multifunctional team and works within the Quality organization to ensure appropriate scientific, regulatory, and quality standards are followed to assure product quality and compliance. Works closely with leadership in External Supply, Process Development, and various other parts of Operations to drive meaningful change and outcomes for Amgen and patients around the world. Provides strategic leadership, direction, and is responsible for fostering a culture of quality and continuous improvement.

Key Responsibilities:
  • Sets and oversees execution of strategy for measuring and continually monitoring health of the quality systems at global external suppliers
  • Determine remediation actions needed and ensure qualified staff have been assigned to execute
  • Focuses operational resources and leads the design of systems that enable expanding capacity and capability to meet increasing complexity and demand
  • Provides quality oversight and guidance in best practices for proactively selecting external suppliers which provide high quality goods and services
  • Leads interpretation of GMP requirements which enable competitive advantage for Amgen
  • Establishes and maintains key quality performance indicators (KPIs) for suppliers within area of responsibility
  • Sets project timelines and priorities for key initiatives and/or team activities
  • Provides expert input into quality issues associated with ongoing operations, projects, and programs
  • Demonstrates deep knowledge of manufacturing and testing requirements in an evolving regulatory environment
  • Leads and develops a global team, providing staff member supervision and on-going coaching; to include leading remote teams
  • Ensures areas of responsibility are staffed, organized, and resourced to ensure GMP obligations are fulfilled
  • Leads cross-functional initiatives that have significant impact for Amgen and its patients
  • Drives Operational Excellence and champions change
  • Strategically plans, analyzes, and manages resources to include budget, contractors, staff, etc.


Basic Qualifications:

Doctorate degree and 6 years of Quality experience

OR

Master's degree and 10 years of Quality experience

OR

Bachelor's degree and 12 years of Quality experience

AND

6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources

Preferred Qualifications:
  • Degree in Biology, Pharmaceutics, Biotechnology, Engineering, Physics or related discipline
  • 15+ years of experience within the pharmaceutical/biotechnology industry
  • Deep and broad understanding of Quality including batch release, complaints, change control, risk management, etc.
  • Problem solving, trouble shooting, and communication skills
  • Demonstrated leadership in various quality functions
  • Ability to remain calm under duress or in stressful situations
  • Ability to understand details, and also flex to understand and communicate strategic intent
  • Ability to articulate issues in a way that is easily understood by executive leadership
  • Creates an environment that promotes growth (develops leaders) and provides the tools to develop the next generation of leaders
  • Makes risk-based decisions based on Amgen First and decision-making processes that reflect Quality beyond compliance
  • Displays a continuous improvement attitude by constantly and directly challenging status quo within team and with peers
  • Direct experience leading complex organizations and serving as a primary point of contact representing the organization with external agencies
  • Experience leading a global team, to include managing the team successfully through significant change
  • Ability to work effectively in global cross-functional teams and in a highly matrixed team environment
  • Fearlessly drives change, efficiency, and a mindset of continuous improvement and evolution
  • Up to 25% domestic and international travel may be required


Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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.

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.



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Posted: 2020-04-30 Expires: 2020-05-31

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Executive Director Quality, Global External Supply

Amgen
Thousand Oaks, CA 91360

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