Senior R&D Supplier Quality Leader (GMP/GDP)

Amgen Inc.; United States; Remote; USD 132,000 - 179,000; Full time

Job summary

Amgen is seeking an R&D Supplier Quality Senior Manager to lead quality oversight of GxP suppliers supporting clinical development. You will drive risk-based decisions, govern supplier quality programs, and partner across R&D and Operations to ensure patient safety and regulatory compliance.

The role requires strong leadership, project management, and knowledge of GMP, GDP, and GCP within a global matrix environment. Travel up to 15% may be required.

Qualifications

• Doctorate with 2+ years of Quality Management or related experience
• Master’s with 4+ years of Quality Management or related experience
• Bachelor’s with 6+ years of Quality Management or related experience

Responsibilities

• Provide risk-based Quality governance and oversight for R&D suppliers, spanning GMP and GDP requirements.
• Facilitate cross-functional R&D and Operations forums for clinical quality issues involving GMP/GDP.
• Coordinate intake and triage of complex supplier and Quality issues with SME involvement.
• Establish fit-for-purpose supplier qualification and oversight strategies across R&D and Operations.
• Develop, negotiate and maintain Quality Agreements with applicable subject matter experts.
• Drive continuous improvement initiatives in collaboration with research and other functions.
• Lead Quality activities for execution of Quality records related to R&D supplier management.
• Define KPIs and monitor trends to drive timely action on supplier quality risks.
• Escalate issues implementing risk-based decisions across a global matrix organization.

Skills

Quality governance

Cross-functional leadership

Regulatory knowledge

GxP awareness

Education

Doctorate degree

Master’s degree

Bachelor’s degree

Associate’s degree

High school diploma

Job description

Amgen is seeking an R&D Supplier Quality Senior Manager to lead quality oversight of GxP suppliers supporting clinical development. You will drive risk-based decisions, govern supplier quality programs, and partner across R&D and Operations to ensure patient safety and regulatory compliance.

The role requires strong leadership, project management, and knowledge of GMP, GDP, and GCP within a global matrix environment. Travel up to 15% may be required.