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Quality Manager, Global Distribution Quality

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Amgen

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Location:
Netherlands , Breda

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

The Quality Manager, 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 Manager 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.

Job Responsibility:

  • 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
  • Master's degree and 6 years of Quality and Compliance experience
  • Bachelor's degree and 8 years of Quality and Compliance experience
  • Associate's degree and 10 years of Quality and Compliance experience
  • High school diploma / GED and 12 years of Quality and Compliance experience

Nice to have:

  • 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
What we offer:
  • 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

Additional Information:

Job Posted:
May 16, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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