GxP Supplier Quality Manager

Quality Assurance Specialist - Supplier Quality responsible for overseeing external supplier quality across Direct Materials and Service Providers, including process validations, audits, inspections, investigations, and regulatory submissions; create, negotiate, and maintain Quality Agreements; manage batch release and change assessment to ensure strict cGMP compliance; collaborate with suppliers to maintain validated, regulatory-compliant processes and analytical methods; develop quality risk management plans to proactively identify supplier compliance risks; drive due diligence for business development and represent Quality on early-stage Technical Development Teams; build strong relationships with internal and external partners to resolve complex regulatory challenges; travel to conduct audits and on-site quality oversight.