30 days old

QA Sr. Manager - External Supplier Site Quality Lead

Amgen
Thousand Oaks, CA 91360
  • Job Code
    120135133
Amgen

Job ID: R-98984
Location: Thousand Oaks, CA, US 91360

Job Summary

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

Key Responsibilities
  • Quality liaison between Amgen and the supplier
  • Negotiator and Approver 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, event 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
  • Lead audit commitments to completion
  • Continuously assess supplier status through periodic monitoring reporting
  • Partner with Operations site lead on issues, improvements, site performance and overall relationship management
  • Up to 20% domestic and international travel required
  • This role must work on-site at Thousand Oaks, CA


Basic Qualifications

Doctorate degree and 2 years of Quality experience in biotech or pharmaceutical industry

OR

Master's degree and 6 years of Quality experience in biotech or pharmaceutical industry

OR

Bachelor's degree and 8 years of Quality experience in biotech or pharmaceutical industry

OR

Associate's degree and 10 years of Quality experience in biotech or pharmaceutical industry

OR

High school diploma / GED and 12 years Quality experience in biotech or pharmaceutical industry

Preferred Qualifications

  • 5+ years of experience overseeing quality of device or combo product suppliers
  • Expert in ISO 13485 and EU MDR regulations
  • Certified auditor
  • 10 + years biotech or pharmaceutical industry experience
  • Experience with Quality Processes and systems such as Trackwise
  • Experience with oversight of Secondary Packaging suppliers
  • History of involvement with inspection 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
  • Strong influencing 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.



PI120135133

Categories

Posted: 2020-05-07 Expires: 2020-06-07

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

QA Sr. Manager - External Supplier Site Quality Lead

Amgen
Thousand Oaks, CA 91360

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast