• Serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Supplier Quality Management (SQM) activities, with primary responsibility for Inspection Readiness and QMS Assessment & Improvement (A&I) programs. • Drive quality excellence across Amgen’s global external network and play a central role in ensuring successful regulatory outcomes. • Own and lead the SQM/GSQ inspection readiness processes, ensuring best-in-class inspection execution and outcomes across global and virtual sites. • Provide strategic and tactical leadership for inspection and audit preparation, inspection and audit room execution (front room/back room), fielding questions, managing change, and guiding teams through inspection and audit activities. • Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites, partnering closely with established site leads and subject matter experts. • Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates to ensure strong audit/inspection preparedness and alignment to regulatory expectations and industry trends. • Maintain and continuously improve inspection readiness processes, including strategy sessions, pressure tests, and readiness tools; represent GSQ in audits, inspections, and global networks. • Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and Amgen Global Quality Compliance internal audits. • Drive proactive identification, communication, and resolution of site and cross-functional compliance risks across the global network. • Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation, testing, training, and post-implementation support for >300 staff. • Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation.