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Senior Specialist, Quality Assurance

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Amgen

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Location:
United States

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Category:
Quality Control

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Contract Type:
Not provided

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Salary:

149651.00 - 168146.00 USD / Year
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Job Description:

Serve as a key Quality leader supporting Global Supplier Quality (GSQ) and Supplier Quality Management (SQM) activities, with primary responsibility for Inspection Readiness and QMS Assessment & Improvement (A&I) programs. Drive quality excellence across Amgen’s global external network and play a central role in ensuring successful regulatory outcomes.

Job Responsibility:

  • Own and lead the SQM/GSQ inspection readiness processes
  • Provide strategic and tactical leadership for inspection and audit preparation, execution, and response
  • Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites
  • Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates
  • Maintain and continuously improve inspection readiness processes
  • Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and internal audits
  • Drive proactive identification, communication, and resolution of site and cross-functional compliance risks
  • Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation
  • Contribute to or lead project teams supporting business objectives including quality systems, continuous improvement, and digital QMS transformation

Requirements:

  • Doctorate degree & 2 years of Quality Compliance experience
  • Master’s degree & 4 years of Quality Compliance experience
  • Bachelor’s degree & 6 years of Quality Compliance experience
  • Associate’s degree & 10 years of Quality Compliance experience
  • High school diploma / GED & 12 years of Quality Compliance experience
  • Bachelor’s degree in Life Sciences or Engineering
  • Experience leading or participating in key roles for Regulatory/Health Authority inspections
  • Experience auditing and defending processes/procedures during inspections
  • 7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
  • Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management
  • Strong understanding of EU and US cGMP, exposure to GDPs, and knowledge of supplier/partner quality challenges
  • Demonstrated ability to work autonomously, communicate effectively, present data clearly, and navigate ambiguity with structured problem-solving
  • Experience leading cross-functional teams and driving continuous improvement initiatives
  • Ability to maintain strong remote working relationships across global teams
  • Ability to travel regionally and internationally as needed

Nice to have:

  • Bachelor’s degree in Life Sciences or Engineering
  • Experience leading or participating in key roles for Regulatory/Health Authority inspections
  • Experience auditing and defending processes/procedures during inspections
  • 7+ years of related pharmaceutical industry experience (manufacturing, process development, QA) with increasing responsibility
  • Experience in quality systems, compliance, data analysis, project management, and supplier/CMO management
  • Strong understanding of EU and US cGMP, exposure to GDPs, and knowledge of supplier/partner quality challenges
  • Demonstrated ability to work autonomously, communicate effectively, present data clearly, and navigate ambiguity with structured problem-solving
  • Experience leading cross-functional teams and driving continuous improvement initiatives
  • Ability to maintain strong remote working relationships across global teams
  • Ability to travel regionally and internationally as needed
What we offer:
  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
  • A discretionary annual bonus program
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible

Additional Information:

Job Posted:
January 27, 2026

Employment Type:
Fulltime
Work Type:
Remote work
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