R&D Quality Compliance Associate - Remote

Amgen Inc. (IR); Northern (KY); Hybrid; USD 89,000 - 121,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking a Senior Associate Quality Compliance to support the RDQ program and drive quality improvements across clinical development activities. This role emphasizes regulatory readiness, CAPA management, and data-driven metrics within a remote U.S. team.

The position requires strong knowledge of Good Clinical Practice, regulatory submissions, and collaboration with cross-functional teams. Competitive benefits and continuous development opportunities are provided.

Qualifications

• Master’s degree or higher or equivalent work experience in science or healthcare.
• Bachelor’s degree with 2+ years of relevant experience or similar combinations per the job listing.
• Familiarity with clinical quality systems and regulatory expectations.

Responsibilities

• Support input of audit responses into QMS and inspection data into IMS.
• Assist CAPA management and deviation closure with objective evidence.
• Prepare weekly metrics for RDQ and Rare Disease teams.
• Assist in inspection readiness activities and knowledge sharing with teams.

Skills

Quality compliance

GCP/GPV/GLP knowledge

ICH GCP knowledge

Data analysis

Audit support

Regulatory submissions

Team collaboration

Education

Master’s degree

Bachelor’s degree + 2 years related experience

Associate’s degree + 6 years related experience

High school diploma/GED + 8 years related experience

Tools

Microsoft Office

Job description

Amgen is seeking a Senior Associate Quality Compliance to support the RDQ program and drive quality improvements across clinical development activities. This role emphasizes regulatory readiness, CAPA management, and data-driven metrics within a remote U.S. team.

The position requires strong knowledge of Good Clinical Practice, regulatory submissions, and collaboration with cross-functional teams. Competitive benefits and continuous development opportunities are provided.