Inspection Readiness Manager

Amgen

Overseeing GCP & IVDR Inspection Readiness & Preparation for clinical trials at Amgen. Leading project management initiatives and supporting regulatory inspection readiness and compliance in clinical operations.

Posted 5/20/2026full-timeRemote • 🇺🇸 United StatesSeniorLead💰 $114,745 - $143,236 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

GCPIVDRInspection ReadinessOperational Qualityproject managementclinical trialsprocess developmentrisk managementbiopharmaceutical clinical researchquality improvement

Soft Skills

leadershipmentorshipcross-functional collaborationproblem-solvingcommunicationinnovationteam managementorganizational skillsinterpersonal skillscontinuous improvement

Certifications

Bachelor Degree in Life SciencesRegistered Nurse (RN)