This QA Sr. Manager role will be primarily responsible for the quality oversight of our external primary component/packaging 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 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
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 suppliers
+ Experience with leading audits
+ Technical knowledge of primary components
+ 10+ years biotech or pharmaceutical industry experience
+ Experience with Quality Processes and systems such as Trackwise
+ Experience with quality oversight of Primary Packaging
+ 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
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._**
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.