R&D Supplier Quality Leader – Senior Manager

Amgen; Washington (District of Columbia); Presencial; USD 150.000 - 190.000; Jornada completa

Descripción de la vacante

Amgen is seeking an experienced R&D Supplier Quality Senior Manager to lead quality governance for external suppliers across GMP, GDP, and GxP activities in the R&D space.

You will collaborate with Quality, Clinical, and Operations to ensure compliant supplier performance, drive risk-based decisions, and implement continuous improvements across global suppliers. Travel up to 15% may be required.

Formación

• Doctorate/Master/Bachelor/Associate/High school with 2–12 years of quality management experience.
• Working knowledge of GCP, GLP, GPvP, GMP, GDP regulations and trends.
• Experience in clinical supply chain quality or oversight of GMP/GDP-regulated services.

Responsabilidades

• Provide risk-based Quality governance for R&D suppliers with cross-GxP scope.
• Facilitate cross-functional R&D and Operations forum for clinical quality issues.
• Coordinate risk-based triage of complex supplier and quality issues with SMEs.
• Develop fit-for-purpose supplier qualification and oversight strategies.
• Support development, negotiation, and maintenance of Quality Agreements.
• Define and maintain KPIs for R&D Supplier Quality and drive continuous improvement.

Conocimientos

Quality governance

Cross-functional leadership

Project management

Regulatory compliance

GxP knowledge

Quality risk management

Supplier quality oversight

Influencing across functions

Educación

Doctorate

Master’s

Bachelor’s

Associate

High school diploma

Descripción del empleo

Amgen is seeking an experienced R&D Supplier Quality Senior Manager to lead quality governance for external suppliers across GMP, GDP, and GxP activities in the R&D space.

You will collaborate with Quality, Clinical, and Operations to ensure compliant supplier performance, drive risk-based decisions, and implement continuous improvements across global suppliers. Travel up to 15% may be required.