Senior Associate, Quality Compliance

Amgen

. Strengthen and advance Amgen’s R&D Quality Management System (QMS) .

Posted 9/30/2026full-timeRemote • United StatesSenior💰 $89,168 - $120,640 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems (QMS) and Good Clinical Practice (GCP) compliance, with a strong focus on clinical development oversight and regulatory submission processes. Proficient in leveraging data analytics and AI tools to enhance workflow efficiency and ensure inspection readiness.

Highest-signal resume keywords

Quality Management System (QMS)Good Clinical Practice (GCP)Regulatory Submission ProceduresData Quality AnalyticsMicrosoft Office Proficiency

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical R&D ActivitiesAudit Response ManagementCAPA Development and ClosureMetric ReportingInspection ManagementRegulatory Compliance KnowledgeInternational GCP RequirementsICH E6R3 Knowledge21 CFR ComplianceDocumentation Preparation

Soft Skills

Attention to DetailInterpersonal SkillsWritten CommunicationVerbal CommunicationProactive Demeanor

Tools & Technologies

Inspection Management SystemSharePointTeamsAI Tools

Industry Keywords

Good Pharmacovigilance Practice (GPV)Good Laboratory Practice (GLP)Regulatory InspectionClinical Programs OversightRare Disease

About the role

Key responsibilities & impact

Strengthen and advance Amgen’s R&D Quality Management System (QMS)
Provide quality support for Amgen programs at all stages of products in clinical development
Input audit responses into QMS
Input site inspection data into the Inspection Management System
Work with deviation owners to ensure timely development and closure of CAPAs
Ensure timely preparation and submission of documentation to the Potentially Reportable Serious Breach committee
Collaborate with Clinical Study Teams to facilitate communication
Prepare weekly metric reports for the General Medicine team, highlighting overdue items and supporting timely closure
Assess the effectiveness of metric reports and optimize them with the data quality analytics team
Facilitate Rare Disease team meetings, including agenda and presentation preparation
Maintain Decision & Action logs and Q&A logs, and follow up with action owners until resolution
Support inspection readiness activities
Provide quality oversight of small clinical programs
Leverage AI tools and technologies to streamline workflows, automate processes, and support data-driven decision-making
Develop lessons learned and best practices documentation
Collaborate with other Amgen R&D Quality functions
Maintain the Rare Disease SharePoint site and Teams channels

Requirements

What you’ll need

Master’s degree OR Bachelor’s degree and 2 years of scientific or healthcare related experience OR Associate’s degree and 6 years of scientific or healthcare related experience OR High school diploma / GED and 8 years of scientific or healthcare related experience
Understanding of Clinical R&D activities and Global Regulations
Experience working within GCP Quality Compliance preferred
Knowledge and application of international requirements of Good Clinical Practice (GCP)(required) or Good Pharmacovigilance Practice (GPV) and/or Good Laboratory Practice (GLP)
Knowledge of R&D processes and operations
Knowledge of the Regulatory Submission and Inspection Management procedures
Ability to work under pressure and maintain flexibility
Attention to detail
Knowledge of ICH E6R3 as well as 21 CFR 11, SO, 54, 56, 58, 312, and 812
Proficiency in Microsoft Office
Professional, proactive demeanor
Strong interpersonal skills
Excellent written and verbal communication skills
Sponsorship for this role is not guaranteed

Benefits

Comp & perks

A 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
Flexible work models where possible
Career development opportunities
Work/life balance
Financial plans with opportunities to save towards retirement or other goals