Associate Director, Project Quality, Vendor Qualification
Core
Provide Quality oversight for external supplier/vendor activities associated with the Module 7/8 Site Expansion Project at CSL Behring Kankakee, ensuring efficient, compliant, and end-to-end business processes for GxP-related raw material suppliers, service providers, and distributors.
Role type
Senior IC Associate Director, Project Quality & Vendor Qualification
Builds
GxP-compliant supply chain for immunoglobulin production expansion
Domain
Pharmaceutical manufacturing (Immunology/Biotherapeutics)
Required skills
GxP regulatory compliance, supplier qualification auditing, risk management, change control, supplier quality agreements, deviation investigation, team leadership, cross-functional collaboration
Preferred skills
Advanced degree in scientific discipline, deep knowledge of CSL Behring plasma business process flow, experience with FDA/PIC/S/EMA/Health Canada regulations
Technologies
GxP systems, audit management tools, supplier quality agreement platforms
Responsibilities
Lead a small team of auditors to conduct on-site and remote audits of external suppliers and service providers; establish standardized auditor qualification requirements; implement risk management tools and supplier monitoring concepts; serve as primary interface for supplier quality matters; participate in change control and deviation review meetings; manage supplier quality agreements; support budgetary planning for external audits.
Seniority
Senior, hands-on IC with team leadership
