Senior QA Manager, Global Supplier Quality

Amgen

Washington (District of Columbia)

Remote

USD 150,000 - 190,000

Full time

5 days ago
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Benefits offered by this job

Discretionary annual bonus
Stock-based incentives
Flexible work models

Job summary

Amgen is seeking a Quality Assurance Senior Manager to oversee the quality of primary component suppliers and be a key member of the cross-functional supplier team. You will drive proactive supplier quality management, regulatory alignment, and successful inspections.

You will lead audits, manage supplier quality agreements, and collaborate with operations, process development, and supply chain to ensure compliant, high-quality outcomes.

Qualifications

  • Doctorate degree and 2 years of Quality experience OR
  • Master’s degree and 4 years of Quality experience OR
  • Bachelor’s degree and 6 years of Quality experience OR
  • Associate’s degree and 10 years of Quality experience OR
  • High school diploma / GED and 12 years of Quality experience

Responsibilities

  • Act as the quality lead for supplier relationships from onboarding through disengagement.
  • Perform proactive quality management of suppliers ensuring regulatory compliance.
  • Negotiate and own quality agreements.
  • Prepare external sites for inspections including playbooks.
  • Represent Amgen at inspections and audits as applicable.
  • Review/Approve supplier investigations, events and changes.
  • Quality approver of deviations, change controls, CAPA, EVs.
  • Drive audit commitments to completion.
  • Lead supplier audit preparation and identify focus areas.

Skills

Quality oversight
Supplier quality management
Audit leadership
Regulatory understanding
Cross-functional collaboration
Project management
Data analytics

Education

Doctorate degree
Master’s degree
Bachelor’s degree
Associate’s degree
High school diploma / GED

Tools

TrackWise
Veeva

Job description

Amgen is seeking a Quality Assurance Senior Manager to oversee the quality of primary component suppliers and be a key member of the cross-functional supplier team. You will drive proactive supplier quality management, regulatory alignment, and successful inspections.

You will lead audits, manage supplier quality agreements, and collaborate with operations, process development, and supply chain to ensure compliant, high-quality outcomes.

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