Associate Director, Project Quality, Vendor Qualification

Main Responsibilities and Accountabilities

• Implement strategic goals established by functional leadership.
• Collaborate with External Supply Quality colleagues to manage overall supplier qualification auditing program including establishment of standardized auditor qualification requirements; on-site, remote or paper audit determination.
• Through the identification and utilization of best-in-class practices, establish appropriate risk management tools, supplier and raw material monitoring concepts.
• Serves as primary M7/8 site interface and point of communication of all supplier quality related matters or issues.
• Attends local deviation review meetings and acts as quality liaison between Supplier and Site (M7/8 project scope) to assist deviation investigation processes.
• Participates in change control process as required.
• Performs quality systems audits of approved and/or potential suppliers of raw materials and components, service providers and distributors, for the M7/8 project.
• May also perform M7/8 project site audits, as requested. Represents and articulates External Supplier Quality policies and procedures during regulatory audits.
• Manages the activities of supplier quality agreements, global and local, which include writing, editing, reviewing, updating and routing the agreements for approvals between CSL New (M7/8) Manufacturing location, service providers and suppliers.
• Supports the generation of fiscal year budgetary planning, ongoing forecasting for all external audits.
• In collaboration with Global Sourcing, develops supportive and ongoing positive relationships with the external quality functions within CSL’s Critical Suppliers.