R&D Supplier Quality Leader

Regulatory Jobs; United States; On-site; USD 104,000 - 141,000; Full time

Job summary

Amgen is seeking a highly motivated R&D Supplier Quality Manager to support the qualification, oversight, and continuous improvement of suppliers contributing to the R&D pipeline. You will ensure compliance, data integrity, and risk mitigation across GxP systems and services.

In this role, you will work cross-functionally with Quality, Procurement, R&D, IS, Cybersecurity, and other business process owners, traveling up to 10% domestically and internationally as needed.

Qualifications

• Must hold a Doctorate, Master’s, Bachelor’s, or equivalent with relevant science/engineering background.
• Experience with GxP regulatory requirements and supplier quality.
• Familiarity with computerised systems validation and data integrity.

Responsibilities

• Conduct risk-based supplier assessments and lifecycle management.
• Lead or support audits of supplier GxP computerized systems.
• Ensure regulatory inspection readiness and CAPA effectiveness.

Skills

GxP knowledge

Quality systems

Supplier audits

Data integrity

Regulatory compliance

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

TrackWise

Audit tools

Job description

Amgen is seeking a highly motivated R&D Supplier Quality Manager to support the qualification, oversight, and continuous improvement of suppliers contributing to the R&D pipeline. You will ensure compliance, data integrity, and risk mitigation across GxP systems and services.

In this role, you will work cross-functionally with Quality, Procurement, R&D, IS, Cybersecurity, and other business process owners, traveling up to 10% domestically and internationally as needed.