20 days old

Senior Manager: External Supplier Quality Management Lead - Device

Amgen
Thousand Oaks, CA 91360
  • Job Code
    134286534
Amgen

Job ID: R-117028
Location: Thousand Oaks, CA, US

This QA Sr. Manager role will be responsible for the quality oversight of multiple device component suppliers. This person is an integral member of the Amgen cross-functional device supplier team that includes, but is not limited to, business operations, process development, supply chain and final product technologies quality.

Key Responsibilities
  • Quality liaison between Amgen and the supplier
  • Negotiator and owner of quality agreements
  • Prepare external site for inspections including development of inspection playbooks.
  • Represent Amgen at external supplier site during product-specific Regulatory Inspections and/or during notified body audits of supplier, as applicable or required
  • Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
  • Review/Approve supplier investigations, events and change notifications
  • Quality approver of deviations, change controls, CAPA, CAPA EVs
  • Identify and mitigate risk at the supplier and/or escalate to management
  • Perform Person in Plant activities, as deemed appropriate
  • Drive audit commitments to completion
  • Lead supplier audit preparation and identify areas of focus
  • Continuously assess supplier status through periodic monitoring reporting
  • Partner with Operations site lead on issues, improvements, site performance and overall relationship management
  • Understand and implement GMP requirements internally and externally
  • Up to 20% domestic and international travel required
  • This role may work on-site at one of the following locations: Thousand Oaks, CA, Cambridge, MA, Greenwich, RI, Tampa, FL, or Puerto Rico.
  • Open to remote associates in any US location

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

High school diploma / GED and 12 years Quality experience

Preferred Qualifications
  • 10+ years biotech or pharmaceutical industry experience
  • 5+ years of experience overseeing quality of suppliers
  • Experience with leading audits
  • Technical knowledge related to molded components
  • 10 + years biotech or pharmaceutical industry experience
  • Experience with Quality Processes and systems such as Trackwise
  • Experience with quality oversight of device components
  • History of presenting during inspections and audits
  • Able to facilitate and influence senior stakeholders and partners
  • Able to successfully prioritize workload and meet timelines
  • Ability to negotiate a strategic position after taking feedback from multiple sources
  • Strong project management, problem-solving, and analytical skills
  • Demonstrated ability to lead cross-functional teams, consistently deliver timely, and high-quality results
  • Collaborates and communicates well with others, able to balance divergent inputs from various partners and drive issue resolution
  • Ability to operate in a matrixed or team environment with site, functional, and executive leadership
  • Experience with relationship management with external parties


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: 2021-04-17 Expires: 2021-05-18

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Senior Manager: External Supplier Quality Management Lead - Device

Amgen
Thousand Oaks, CA 91360

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