• Reporting to the Vice President, Quality, the Director/Sr. Director, Vendor Quality Management provides strategic and operational leadership for the qualification, oversight, and performance management of contract manufacturers (CMOs), contract laboratories, suppliers, and service providers supporting GxP activities. • Establish and maintain a risk-based vendor qualification and requalification program • Define vendor risk classification criteria and oversight frequency • Oversee vendor assessments and approval processes • Monitor vendor performance through quality metrics • Lead vendor transition or discontinuation activities as needed • Oversee development and maintenance of Quality Agreements • Ensure agreements clearly define roles and responsibilities • Align Quality Agreements with business contracts • Periodically review and update agreements • Establish vendor performance metrics • Conduct Quality Business Reviews with key vendors • Implement risk-based monitoring strategies • Proactively identify and mitigate compliance risks • Ensure vendor oversight documentation supports inspection readiness • Participate in regulatory inspections • Coordinate vendor support during inspections • Oversee remediation related to vendor findings • Partner with CMC, Clinical Operations, Clinical Development, Supply Chain, Commercial, Regulatory, Legal and other functions as needed • Provide vendor compliance risk expertise during program planning • Support new product introductions and technology transfers as needed • Benchmark vendor oversight practices • Drive digital enablement of vendor management systems • Promote proactive quality culture across partner network