R&D Supplier Quality Manager

Amgen

. Support qualification, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline .

Posted 10/9/2026full-timeRemote • United StatesSeniorLead💰 $104,287 - $141,095 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in supplier quality management processes, particularly in GxP compliance, risk assessment, and oversight of computerized systems. Proficient in evaluating supplier performance and ensuring adherence to regulatory standards while fostering continuous improvement initiatives.

Highest-signal resume keywords

GxP ComplianceSupplier Quality ManagementRisk AssessmentComputerized System ValidationAudit Practices

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier Quality Risk AssessmentGxP Computerized Systems OversightValidation PrinciplesData IntegrityChange ManagementCAPA ManagementAudit Trail EvaluationElectronic Records ManagementAI-Enabled GxP SystemsISO Standards Knowledge

Soft Skills

Excellent Communication SkillsProblem-Solving AbilitiesDetail-OrientedProactive CollaborationRelationship-Building Skills

Tools & Technologies

VeevaTrackWise

Industry Keywords

GCPGLPGPvPR&D PipelineSupplier GovernanceQuality AgreementsContinuous ImprovementCross-Functional TeamsMatrixed EnvironmentRegulatory Compliance

Tech Stack

Tools & technologies

CloudGoogle Cloud Platform

About the role

Key responsibilities & impact

Support qualification, oversight, and continuous improvement of suppliers contributing to Amgen’s R&D pipeline
Execute supplier quality management processes for R&D suppliers under GCP, GLP, and GPvP regulations
Oversee suppliers providing, hosting, developing, validating, maintaining, or supporting GxP computerized systems
Conduct risk-based supplier assessments, qualification, audits, and lifecycle management, including quality agreements
Lead or support qualification and ongoing oversight of suppliers using or providing GxP computerized systems, interfaces, and devices
Assess and oversee supplier AI-enabled GxP computerized systems for compliance with procedural controls, policies, and standards
Plan, lead, and document risk-based audits of supplier GxP computerized systems and quality processes
Assess supplier controls for validation, data integrity, security, access management, change and configuration management, incidents, backup, recovery, business continuity, and decommissioning
Review quality and technical requirements in supplier contracts and quality agreements
Participate in supplier governance and periodic reviews; evaluate performance, validation status, changes, deviations, incidents, audit outcomes, emerging risks, and CAPA effectiveness
Support inspection readiness and regulatory responses related to supplier computerized systems
Monitor supplier performance, track KPIs, and escalate quality issues
Coordinate and/or execute supplier audits, manage findings, initiate quality records, and ensure timely CAPA closure
Maintain supplier data in quality systems such as Veeva and TrackWise
Engage suppliers on requirements, governance, and process improvement initiatives
Ensure procedural compliance, perform quality checks, and contribute to continuous improvement
Collaborate with R&D, Supply Chain, Sourcing, and QA teams on supplier quality strategies

Requirements

What you’ll need

Doctorate degree OR Master’s degree and 2 years of Science, Engineering, or experience in a related field OR Bachelor’s degree and 4 years of Science, Engineering, or experience in a related field OR Associate’s degree and 8 years of Science, Engineering, or experience in a related field OR High school diploma / GED and 10 years of Science, Engineering, or experience in a related field
Knowledge of GxP, ISO standards, and regulatory expectations for R&D suppliers
Experience with supplier quality risk assessment tools and audit practices
Working knowledge of computerized system validation and assurance principles
Knowledge of risk-based system lifecycle practices and expectations for electronic records, electronic signatures, audit trails, and data integrity
Experience assessing or overseeing GxP technology suppliers, including software, software-as-a-service, cloud, hosting, infrastructure, implementation, validation, and managed service providers
Ability to evaluate supplier audit reports, validation plans and reports, requirements and traceability, testing evidence, security and continuity controls, change records, deviations, CAPAs, and service performance data
Experience and proficiency in overseeing AI-enabled GxP systems, including risk assessment, governance, validation, data integrity, and ongoing supplier monitoring
Excellent written and verbal communication skills
Ability to work effectively in cross-functional teams and in a matrixed environment
Strong problem-solving and critical thinking abilities
Detail-oriented with a continuous improvement mindset
Proactive collaboration and relationship-building skills
Ability to manage multiple priorities and deliver results under timelines
Sponsorship for this role is not guaranteed

Benefits

Comp & perks

Retirement and Savings Plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible
Career development opportunities
Work/life balance support
Up to 10% domestic and international travel may be required for supplier engagements and audits