R&D Supplier Quality Leader — GxP, AI Systems, Flexible Work

Amgen; Washington (District of Columbia); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Amgen is seeking a highly capable R&D Supplier Quality Manager to support qualifications, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline. You will work with Quality, Procurement, R&D, IT, Cybersecurity and other stakeholders to ensure data integrity, patient safety, and regulatory compliance.

The role emphasizes GxP computerized systems, risk-based audits, and lifecycle management across preclinical and clinical activities, with up to 10% travel and a

Qualifications

• PhD or Master’s with 2+ years in Sci/Eng or related field or 4+ years with Bachelor’s in Sci/Eng
• 8–10 years total experience for high school route acceptable

Responsibilities

• Conduct risk-based supplier assessments and lifecycle management
• Lead or support qualification and oversight of GxP computerized systems
• Plan and document risk-based audits of supplier systems
• Review quality and technical requirements in supplier contracts and quality agreements
• Coordinate supplier audits and CAPA closure
• Maintain supplier data in quality systems to ensure inspection readiness
• Collaborate with R&D, QA, Sourcing, and Supply Chain to implement supplier quality strategies

Skills

Written communication

Verbal communication

Cross-functional teamwork

Problem solving

Attention to detail

Prioritization

Process improvement

Proactive collaboration

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Tools

Veeva

TrackWise

GxP validation

Job description

Amgen is seeking a highly capable R&D Supplier Quality Manager to support qualifications, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline. You will work with Quality, Procurement, R&D, IT, Cybersecurity and other stakeholders to ensure data integrity, patient safety, and regulatory compliance.

The role emphasizes GxP computerized systems, risk-based audits, and lifecycle management across preclinical and clinical activities, with up to 10% travel and a