R&D Supplier Quality Sr Manager
Core
Deliver a robust, risk-based supplier quality program for R&D suppliers and service providers supporting clinical development activities, ensuring GxP compliance and preventing critical quality issues.
Role type
Senior Individual Contributor (Supplier Quality Management)
Builds
Risk-based supplier qualification strategies, Quality Agreements, and oversight frameworks for GxP-regulated R&D suppliers.
Domain
Life Sciences / Biotechnology / Clinical Development / Regulatory Quality
Required skills
GMP, GDP, GCP, GLP, GPvP regulatory knowledge, Quality Risk Management, supplier qualification, cross-functional leadership, project management, contract negotiation, KPI definition, process improvement.
Preferred skills
Clinical supply chain quality experience, global matrix organization experience, transactional lean/value stream mapping, ambiguity navigation.
Technologies
Quality management systems, supplier management tools.
Responsibilities
Provide risk-based Quality governance and oversight for R&D suppliers; Support cross-functional forums for clinical quality issues; Coordinate intake and triage of complex supplier issues; Partner on supplier qualification strategies; Develop and maintain Quality Agreements; Drive continuous improvement initiatives; Define and monitor Supplier Quality KPIs; Escalate supplier-quality risks affecting patient safety or compliance.
Seniority
Senior, hands-on IC with strategic oversight
