R&D Supplier Quality Sr Manager

Amgen seeks an R&D Supplier Quality Senior Manager to oversee quality compliance for GxP-regulated suppliers and service providers supporting clinical development. This remote role manages supplier relationships, risk assessments, cross-functional coordination, and quality governance within the Precision Medicine, Diagnostics and Supplier Quality organization.

Responsibilities

• Provide risk-based quality governance and oversight for R&D suppliers spanning GCP, GLP, GPvP, GMP, and GDP requirements
• Facilitate cross-functional forum addressing clinical quality issues with unclear ownership or multiple stakeholder involvement
• Coordinate intake and triage of complex supplier quality issues, identifying applicable requirements and accountable functions
• Establish and maintain quality agreements and supplier qualification strategies for activities crossing R&D and Operations boundaries
• Define KPIs and metrics for R&D supplier quality to identify trends and drive timely corrective action

Requirements

• Doctorate degree with 2+ years quality management experience, or equivalent combination of education and experience
• Strong knowledge of GMP, GDP, GCP, GLP, and GPvP regulations and practices
• Experience in supplier quality management or clinical supply chain oversight
• Expertise in quality risk management and project management methodologies
• Proven ability to lead cross-functional initiatives and influence across matrixed organizations