R&D Supplier Quality Leader—GxP & AI Systems

Amgen SA; Northern (KY); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Total Rewards Plan

Stock-based long-term incentives

Flexible work models

Job summary

Amgen in the United States is seeking an experienced R&D Supplier Quality Manager to support qualification, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline.

You will work cross-functionally with Quality, Procurement, R&D, Information Systems, Cybersecurity, and others to ensure compliance, data integrity, patient safety, and timely CAPA closure across supplier quality systems.

Qualifications

• Doctorate, or Master’s with 2+ years in science/engineering related field.
• Bachelor’s with 4+ years in science/engineering; or equivalent.
• Experience with GxP, ISO standards, and regulatory expectations for R&D suppliers.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Conduct risk-based supplier assessments and lifecycle management.
• Lead audits of supplier GxP computerized systems and quality processes.
• Ensure data integrity, security, and CAPA effectiveness across supplier lifecycle.
• Coordinate supplier governance and track KPIs.

Skills

Quality management

Audit & compliance

Risk assessment

Cross-functional collaboration

GxP systems knowledge

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

TrackWise

GxP validation tools

Job description

Amgen in the United States is seeking an experienced R&D Supplier Quality Manager to support qualification, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline.

You will work cross-functionally with Quality, Procurement, R&D, Information Systems, Cybersecurity, and others to ensure compliance, data integrity, patient safety, and timely CAPA closure across supplier quality systems.