Job Overview
Location
United States - Remote
Job Type
Full-time
Category
HR & Recruiting
Date Posted
May 20, 2026
Full Job Description
đź“‹ Description
- • As an Inspection Readiness Manager at Amgen, you will play a vital role in ensuring the company’s clinical trials meet the highest standards of quality and regulatory compliance, directly supporting the mission to deliver safe and effective therapies to over 10 million patients worldwide.
- • You will own and lead GCP and IVDR regulatory site inspection readiness and preparation project management across early, late, and observational clinical programs, driving smooth inspection experiences and successful outcomes through cross-functional collaboration and innovation.
- • You will be part of Amgen’s Operational Quality team within Clinical Operations, a global team dedicated to ensuring adherence to ICH GCP, protecting trial subject rights and safety, and maintaining credible clinical trial data through inspection readiness, trial master file support, and risk management.
- • In this role, you will deepen your expertise in drug development, regulatory quality systems, and operational excellence, while developing leadership and mentoring skills by guiding interns and influencing continuous improvement initiatives across global clinical programs.
🎯 Requirements
- • Bachelor Degree in Life Sciences or RN or equivalent
- • 7 years work experience in life sciences or medically related field, including 6 years of biopharmaceutical clinical research experience working on clinical trials at a biotech, pharmaceutical or CRO company
- • Experience of, or oversight of global clinical trial conduct
- • Experience driving and leading process development and/or improvement
- • Experience as an Inspection, or Risk Manager, preferred
🏖️ Benefits
- • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
- • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
- • 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
Skills & Technologies
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About Amgen Inc.
Amgen Inc. is a global biotechnology company headquartered in Thousand Oaks, California. Founded in 1980, it discovers, develops, manufactures, and delivers human therapeutics targeting cancer, kidney disease, rheumatoid arthritis, bone disease, and other serious illnesses. Using advanced recombinant DNA and molecular biology techniques, Amgen produces biologic medicines such as Neulasta, Enbrel, and Prolia. The company operates R&D, manufacturing, and distribution facilities worldwide, investing heavily in genomic research to identify novel drug targets. Amgen also partners with academic institutions and smaller biotechs to expand its pipeline, aiming to transform breakthrough science into therapies that significantly improve patients’ lives.
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