R&D Supplier Quality Lead – GMP/GDP & Clinical Oversight

Amgen SA; United States; Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Retirement plan

Health insurance

Stock-based incentives

Flexible work models

Job summary

Amgen is seeking an R&D Supplier Quality Senior Manager to oversee quality governance for external suppliers involved in GxP activities across GMP and GDP. The role collaborates with R&D and Operations to ensure compliant, risk-based supplier oversight and continuous improvement.

The successful candidate will have strong GMP/GDP/GCP experience, project leadership skills, and the ability to drive cross-functional decisions in a global, matrixed environment.

Qualifications

• Degree and experience requirements for QM roles as listed in the posting.
• Regulatory knowledge in GCP/GLP/GMP/GDP is preferred.
• Experience with supplier quality management in clinical development is desirable.

Responsibilities

• Provide risk-based quality governance for R&D suppliers across GxP.
• Lead cross-functional forums for clinical quality issues involving GMP/GDP.
• Coordinate risk-based triage of supplier and quality issues with accountable functions.
• Develop supplier qualification and oversight strategies for cross-boundary activities.
• Support quality agreements and continuous improvement initiatives.

Skills

Quality Management

Cross-functional Leadership

Regulatory Knowledge

Education

Doctorate + 2y QM

Master’s + 4y QM

Bachelor’s + 6y QM

Associate + 10y QM

High school + 12y QM

Job description

Amgen is seeking an R&D Supplier Quality Senior Manager to oversee quality governance for external suppliers involved in GxP activities across GMP and GDP. The role collaborates with R&D and Operations to ensure compliant, risk-based supplier oversight and continuous improvement.

The successful candidate will have strong GMP/GDP/GCP experience, project leadership skills, and the ability to drive cross-functional decisions in a global, matrixed environment.