Quality Assurance Senior Manager
Amgen
Google Cloud Platform
R&D Supplier Quality Manager
Amgen
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $107,900 - $129,382 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- R&D Supplier Quality Manager overseeing risk-based supplier quality for Amgen PMDSQ
- Implement and maintain supplier qualification and oversight activities across GCP, GLP, and GPvP regulatory frameworks
- Monitor supplier quality performance metrics and CAPA closure
- Lead supplier audit coordination and ongoing data integrity in electronic quality systems
- Collaborate with cross-functional teams including R&D, Supply Chain, Procurement, and QA to align on onboarding and operational requirements
Requirements
- Doctorate degree OR Master’s degree and 3 years of relevant experience OR Bachelor’s degree and 5 years of relevant experience OR Associate’s degree and 10 years of relevant experience OR High school diploma / GED and 12 years of relevant experience
- In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
- Experience within the pharmaceutical/biotech or medical device industry working in quality management systems role or other relevant experience in a clinical research environment that includes quality oversight (e.g. deviation management/CAPA, audit conduct, or inspection support)
- Supplier quality management experience
- Audit and risk management training/certification
- Familiarity with GxP and ISO standards applicable to R&D suppliers
- Strong project management skills
- Experience working in a global, matrixed organization across multiple time zones
- Working knowledge of GCP, GLP and GPvP regulations, practices, and trends
- Experience and results in the areas of implementing new regulations and standards, gap assessment, QMS processes
- Flexibility in work hours being in PST or EST
