Career Category

Quality

Job Description

Quality Specialist, Global Distribution Quality

LIVE

What you will do

The Quality Specialist, Global Distribution Quality, will serve as a key member of Amgen's global quality organization, providing quality assurance oversight for global distribution operations, transportation quality systems, and distribution-related partners and service providers. This role will act as a subject matter expert for Good Distribution Practices, controlled temperature shipping, distribution documentation, quality systems, deviations, complaints, audits, inspections, and transportation lane assessments. The Quality Specialist will partner closely with Global Supply Chain, Regional Quality, Global Distribution Hubs, the Global Transportation Excellence Team, Thermal Engineering Systems, manufacturing sites, and external distribution partners to ensure Amgen products are transported and distributed in compliance with applicable regulations, internal standards, and patient-focused quality expectations. This role requires strong technical judgment, operational discipline, stakeholder influence, and the ability to work effectively in complex, global, and cross-functional environments.

Key Responsibilities:

• 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.

WIN

What we expect of you

Minimum 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.

Preferred Qualifications:

• 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.

Core Competencies:

• Technical mastery in distribution quality, quality systems, GDP, documentation, and compliance expectations.

• Precision and accountability in execution, documentation, and oversight of regulated processes.

• Strong problem-solving capability, including root cause thinking, deviation support, risk identification, and prevention-focused decision-making.

• Analytical thinking and ability to interpret data, trends, quality risks, and operational impacts.

• Compliance leadership, including inspection readiness, audit support, and constructive challenge when standards are at risk.

• Project and initiative execution with clear ownership, timely delivery, and proactive risk management.

• Cross-functional partnership, stakeholder influence, and clear communication across sites, regions, functions, and external partners.

• Commitment to high performance, continuous improvement, and development of others through coaching, knowledge-sharing, and collaboration.

Location and Travel

This role may be based in ABR, with regional and global responsibilities across manufacturing sites, supply hubs, distribution partners, and cross-functional teams. Travel may be required.

THRIVE

WHAT YOU CAN EXPECT OF US

As we work to develop treatments that take care of others, we also care deeply for our teammates’ well-being and growth.

• Vast opportunities to learn, develop, and move up and across our global organization.

• Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.

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

• Flexible work arrangements.

APPLY NOW

Objects in your future are closer than they appear. Join us.

CAREERS.AMGEN.COM

EQUAL OPPORTUNITY STATEMENT

AMGEN is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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