Amgen
10,000+ employees
Founded 1980
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
💰 $28.5G Post-IPO Debt on 2022-12
Biotechnology • Pharmaceuticals • Science
Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.
Inspection Readiness Manager
🕒 May 20
🇺🇸 United States – Remote
💵 $114.7k - $143.2k / year
⏰ Full Time
🟠 Senior
🔴 Lead
👔 Manager
🦅 H1B Visa Sponsor
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Amgen
10,000+ employees
Founded 1980
🧬 Biotechnology
💊 Pharmaceuticals
🔬 Science
💰 $28.5G Post-IPO Debt on 2022-12
Biotechnology • Pharmaceuticals • Science
Amgen is a global leader in biotechnology, focusing on the development and commercialization of innovative medicines made from living cells. The company aims to treat serious illnesses, often targeting diseases with limited therapeutic options. Amgen emphasizes scientific innovation and is committed to ethical research, patient safety, and environmental sustainability. It actively engages in clinical trials and is known for its contributions to the fields of cancer treatment and obesity management among others.
📋 Description
• Oversee the execution of high-quality GCP & IVDR Inspection Readiness & Preparation • Own the Site Inspection Readiness & Preparation project management for all clinical trials and programs covering early, late, and observational programs • Participate in developing and implementing innovative cross-functional Inspection Readiness (IR), Inspection Preparation, and Operational Quality (OQ) initiatives • Lead GCP & IVDR Regulatory Site Inspection Readiness and Preparation project management using tools, materials, apps and systems • Leading teams through smooth inspection experiences and successful inspection outcomes • Innovate continuous improvement in operational quality inspection readiness by identifying and acting on program, study and site quality incidents • Maintain and manage IR SharePoint (SPO) site • Providing mentorship to student interns
🎯 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 • flexible spending accounts • A discretionary annual bonus program • Stock-based long-term incentives • Award-winning time-off plans • bi-annual company-wide shutdowns • Flexible work models, including remote work arrangements, where possible
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