Quality Manager, Global Distribution Quality

Role Overview

• Provide quality assurance oversight for Amgen's Global Distribution Hubs, transportation processes, and distribution-related quality systems.
• Serve as a subject matter expert for Good Distribution Practices, transportation quality requirements, distribution documentation, and applicable procedures.
• Support the selection, qualification, approval, and ongoing quality oversight of distribution partners, suppliers, third-party service providers, and transportation-related vendors.
• Provide QA support for distribution deviations, complaints, transportation lane assessments, change controls, and related investigations.
• Partner with Supply Chain and cross-functional teams to assess and support productivity, transformation, and cost-saving initiatives while maintaining compliance and product quality.
• Collaborate with Thermal Engineering Systems to implement, qualify, and continuously improve Controlled Temperature Shipping Systems.
• Support audits and inspections of manufacturing sites, supply hubs, distribution partners, and third-party service providers.
• Execute internal assessments and audits, develop clear reports, communicate findings, and support timely completion of corrective and preventive actions.
• Apply risk-based and data-driven decision-making to identify quality risks, evaluate controls, and recommend preventive measures.
• Represent Quality in cross-functional meetings, quality forums, management reviews, inspection readiness activities, and project teams.
• Communicate complex quality issues clearly and effectively to stakeholders, including leadership, site teams, regional teams, and external partners.
• Promote strict adherence to procedures, documentation standards, GDP expectations, and applicable regulatory requirements.
• Contribute to global quality initiatives, continuous improvement efforts, and harmonization of distribution quality practices across the network.

Requirements

• Doctorate degree and 2 years of Quality and Compliance experience; or Master's degree and 6 years of Quality and Compliance experience; or Bachelor's degree and 8 years of Quality and Compliance experience; or Associate's degree and 10 years of Quality and Compliance experience; or High school diploma / GED and 12 years of Quality and Compliance experience.
• Strong Experience in Quality Assurance, Distribution Quality, Supply Chain Quality, Manufacturing Quality, or Quality Compliance within a regulated pharmaceutical, biotechnology, or life sciences environment.
• Knowledge of Good Distribution Practices, cGMP expectations, quality systems, documentation practices, deviations, distribution complaints, CAPA, change control, audits, and inspections.
• Experience supporting global distribution, transportation, cold chain, controlled temperature shipping, logistics, supplier quality, or third-party service provider oversight.
• Ability to interpret regulatory requirements, internal procedures, and quality standards and apply them to complex or ambiguous operational situations.
• Demonstrated ability to make data-driven, risk-based decisions and translate technical information into clear recommendations.
• Strong project execution skills, including planning, stakeholder alignment, risk management, issue escalation, and timely delivery of quality outcomes.
• Proven ability to build effective partnerships across Quality, Supply Chain, Manufacturing, Engineering, Regional Quality, and external partners.
• Strong written and verbal communication skills, including the ability to prepare reports, present findings, and influence stakeholders.
• Ability to manage multiple priorities in a dynamic global environment while maintaining attention to detail and compliance.
• Demonstrated commitment to continuous improvement, operational excellence, and Amgen's mission to serve patients.

Benefits

• Generous AMGEN Total Rewards Plan comprising healthcare, finance, wealth, and career benefits.
• Flexible work arrangements.