R&D Supplier Quality Manager
Core
Manage qualifications, oversight, and continuous improvement of R&D suppliers providing GxP computerized systems, AI-enabled tools, and services for preclinical and clinical activities.
Role type
Senior IC Supplier Quality Manager (R&D)
Builds
Compliant supplier lifecycle management for regulated R&D services and GxP systems
Domain
Biotechnology / Regulated R&D / GxP Compliance
Required skills
Risk-based supplier assessment, GxP compliance, Computerized system validation, Data integrity, Audit management, CAPA management, Contract review, Regulatory inspection support, AI system governance, Cross-functional collaboration
Preferred skills
Life Sciences or Engineering degree, GxP/ISO standards knowledge, Supplier risk assessment tools, GxP technology supplier oversight, AI-enabled GxP systems experience, Audit report evaluation
Technologies
Veeva, TrackWise, GxP computerized systems, AI-enabled systems
Responsibilities
Conduct risk-based supplier assessments, qualification, audit and lifecycle management; Lead oversight of suppliers utilizing GxP computerized systems and AI-enabled tools; Plan and document risk-based audits of supplier systems; Review quality requirements in supplier contracts; Monitor supplier performance and KPIs; Coordinate supplier audits and CAPA closure; Maintain supplier data in quality systems.
Seniority
Senior, hands-on IC
