R&D Supplier Quality Leader, Global GMP/GDP

BioSpace; Washington (District of Columbia); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Stock-based long-term incentives

Retirement and Savings Plan

Flexible work models

Job summary

Amgen in the United States seeks an experienced R&D Supplier Quality Senior Manager to deliver risk-based quality governance for external suppliers. You will drive oversight for GMP/GDP-relevant activities, manage cross-functional forums, and ensure timely escalation and resolution of critical quality issues.

The role emphasizes collaboration across R&D and Operations, with responsibilities spanning supplier qualification, quality agreements, and continuous improvement in a global matrix

Qualifications

• Experience in supplier quality management or oversight.
• Knowledge of GCP, GLP, GPvP, GMP, GDP regulations and trends.
• Experience in clinical supply chain quality or oversight of GMP/GDP services.
• Ability to influence and drive progress across functions.

Responsibilities

• Provide risk-based Quality governance for R&D suppliers across GxP.
• Facilitate cross-functional forums for clinical quality issues involving GMP/GDP requirements.
• Coordinate triage of complex supplier and quality issues with SMEs.
• Develop supplier qualification and oversight strategies for cross-boundary activities.
• Draft and maintain Quality Agreements and supplier quality requirements.
• Lead quality-record execution for R&D supplier management.

Skills

Leadership

Project management

Communication

Cross-functional collaboration

Education

Doctorate degree + 2 years Quality Management

Masters degree + 4 years Quality Management

Bachelors degree + 6 years Quality Management

Associates degree + 10 years Quality Management

High school diploma + 12 years Quality Management

Job description

Amgen in the United States seeks an experienced R&D Supplier Quality Senior Manager to deliver risk-based quality governance for external suppliers. You will drive oversight for GMP/GDP-relevant activities, manage cross-functional forums, and ensure timely escalation and resolution of critical quality issues.

The role emphasizes collaboration across R&D and Operations, with responsibilities spanning supplier qualification, quality agreements, and continuous improvement in a global matrix