Drive Supplier Quality Processes and Procedures improvements with the Supplier Quality team, as well as maintenance, to applicable standards and requirementsRepresent at various Management Reviews and lead Quality Plans/CAPA for the department as neededEnsure department audit readiness and provide front/backroom support as neededDetermine Supplier Quality data and records management and future strategiesDrive adherence and metric reviews as well as enhancements in Approved Supplier List, Supplier Corrective Action, Scorecarding, Supplier Audit, and Supplier Change Notice requirements

Provide supplier quality management support to external manufacturers. Ensure alignment of SQM quality systems of EM sites with the current regulatory requirements, J&J standards and policies and procedures. Apply purchasing controls over EM’s to ensure compliance to Quality System and Regulatory requirements. Negotiate and revise Supplier Quality Agreements, support lifecycle management projects and drive overall progress in supplier quality performance. Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks and drive resolution of supplier quality issues and risk control processes.

4years