Amgen QA Sr. Manager – External Supplier Site Quality Lead in Thousand Oaks, California
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.
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
Doctorate degree and 2 years of Quality experience in biotech or pharmaceutical industry
Master’s degree and 6 years of Quality experience in biotech or pharmaceutical industry
Bachelor’s degree and 8 years of Quality experience in biotech or pharmaceutical industry
Associate’s degree and 10 years of Quality experience in biotech or pharmaceutical industry
High school diploma / GED and 12 years Quality experience in biotech or pharmaceutical industry
5+ years of experience overseeing quality of device or combo product suppliers
Expert in ISO 13485 and EU MDR regulations
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
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.