R&D Supplier Quality Leader, Flexible Work Model

Amgen Inc.; United States; Remote; USD 104,000 - 141,000; Full time

Benefits offered by this job

Comprehensive benefits package

Stock-based incentives

Flexible work options

Career development opportunities

Job summary

Amgen in the United States is seeking a highly motivated R&D Supplier Quality Manager to support qualification, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline and mission to serve patients.

You will lead risk-based supplier assessments, audits, and lifecycle management across GxP systems, ensuring data integrity, security, and regulatory compliance, with travel up to 10%.

Qualifications

• Doctorate or advanced degree in Life Sciences, Engineering, or related field.
• Strong knowledge of GxP, ISO standards and regulatory expectations.
• Experience with supplier quality risk assessment and audits.
• Experience with AI-enabled GxP systems preferred.
• Ability to work in cross-functional teams and in a matrixed environment.

Responsibilities

• Conduct risk-based supplier assessments, qualification, audit and lifecycle management with quality agreements.
• Lead or support risk-based qualification and oversight of suppliers using GxP computerized systems.
• Assess supplier AI-enabled GxP systems to ensure data integrity, security, and controls.
• Plan, lead, and document risk-based audits of supplier GxP systems and processes.
• Review supplier quality systems for lifecycle management including validation and change control.
• Monitor supplier performance, KPIs, and drive CAPA closure and governance.

Skills

Quality management

GxP

Audits

Data integrity

Regulatory knowledge

Cross-functional collaboration

Risk assessment

Education

Doctorate

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

TrackWise

GxP software tools

Job description

Amgen in the United States is seeking a highly motivated R&D Supplier Quality Manager to support qualification, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline and mission to serve patients.

You will lead risk-based supplier assessments, audits, and lifecycle management across GxP systems, ensuring data integrity, security, and regulatory compliance, with travel up to 10%.