Quality Compliance Senior Manager
November 11
🇺🇸 United States – Remote
💵 $144.3k - $174.2k / year
⏰ Full Time
🟠 Senior
🚔 Compliance
🦅 H1B Visa Sponsor
Description
• Join Amgen’s mission of serving patients by providing proactive quality support • Help implement a risk-based quality assurance strategy for clinical development programs • Ensure Amgen’s business procedures meet internal and external quality standards • Collaborate with quality professionals within R&D to support the QMS continuous improvement cycle • Facilitate a robust regulatory intelligence system monitoring changing regulations
Requirements
• Doctorate degree and 2 years of quality experience OR Master’s degree and 6 years of quality experience OR Bachelor’s degree and 8 quality experience OR Associate’s degree and 10 years of quality experience OR High school diploma / GED and 12 years of quality experience • Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs • 7 years or more experience in quality management, quality assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are core responsibilities • Experience in a coding language like Python or R, is preferred • Skilled translator between technical and non-technical audiences to deliver fit for purpose tools • Solid understanding of SOP/Standards management and methods/technology used to drive knowledge management across a diverse R&D environment
Benefits
• Comprehensive employee benefits package, including Retirement and Savings Plan with generous company contributions • Group medical, dental and vision coverage • Life and disability insurance • Flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans and bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible
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