R&D Supplier Quality Leader — GxP Compliance & Audits

Amgen; Thousand Oaks (CA); Hybrid; USD 104,000 - 141,000; Full time

Benefits offered by this job

Retirement plan

Stock-based incentives

Flexible work arrangements

Job summary

Amgen Inc. is seeking an R&D Supplier Quality Manager to ensure supplier quality across the R&D pipeline, including GxP computerised systems, data integrity, and regulatory compliance.

The role collaborates with Quality, Procurement, R&D, IS, and Cybersecurity to drive risk-based oversight and continuous improvement. Responsibilities include risk-based supplier assessments, audits, CAPA management, and support for regulatory responses.

Qualifications

• Doctorate degree or Master’s degree with 2+ years in science/engineering or related field; or Bachelor’s with 4+ years; or Associate’s with 8+ years; or HS diploma with 10+ years in related science/engineering field.

Responsibilities

• Conduct risk-based supplier assessments and lifecycle management.
• Lead qualification and oversight of suppliers using GxP computerized systems.
• Audit supplier GxP computerized systems and related quality processes.
• Plan and document supplier quality audits and CAPA effectiveness.
• Coordinate supplier governance reviews and regulatory readiness.

Skills

Quality management

Supplier quality

GxP compliance

Audits

Risk assessment

Data integrity

Cross-functional collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

TrackWise

Job description

Amgen Inc. is seeking an R&D Supplier Quality Manager to ensure supplier quality across the R&D pipeline, including GxP computerised systems, data integrity, and regulatory compliance.

The role collaborates with Quality, Procurement, R&D, IS, and Cybersecurity to drive risk-based oversight and continuous improvement. Responsibilities include risk-based supplier assessments, audits, CAPA management, and support for regulatory responses.