Amgen

Senior Specialist, Quality Assurance

Amgen

full-time

Posted on:

Location Type: Remote

Location: United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $149,651 - $168,146 per year

Job Level

Senior

About the role

  • 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.
  • Own and lead the SQM/GSQ inspection readiness processes, ensuring best-in-class inspection execution and outcomes across global and virtual sites.
  • Provide strategic and tactical leadership for inspection and audit preparation, inspection and audit room execution (front room/back room), fielding questions, managing change, and guiding teams through inspection and audit activities.
  • Act as a front-room representative for QMS audits and inspections for External Supply Virtual Sites, partnering closely with established site leads and subject matter experts.
  • Collaborate broadly across GSQ, SQM Global Process Owners (GPO), Amgen site networks, and Affiliates to ensure strong audit/inspection preparedness and alignment to regulatory expectations and industry trends.
  • Maintain and continuously improve inspection readiness processes, including strategy sessions, pressure tests, and readiness tools; represent GSQ in audits, inspections, and global networks.
  • Lead or support responses and improvement actions resulting from Regulatory Agency inspections, Business Partner audits, and Amgen Global Quality Compliance internal audits.
  • Drive proactive identification, communication, and resolution of site and cross-functional compliance risks across the global network.
  • Act as SME for QMS A&I processes, supporting major initiatives such as DQMS Phase 2 implementation, testing, training, and post-implementation support for >300 staff.
  • 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 OR Master’s degree & 4 years of Quality Compliance experience OR Bachelor’s degree & 6 years of Quality Compliance experience OR Associate’s degree & 10 years of Quality Compliance experience OR High school diploma / GED & 12 years of Quality Compliance experience
  • Experience leading or participating in key roles for Regulatory/Health Authority inspections, including preparation, execution, and response phases
  • 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.
Benefits
  • 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
  • flexible spending accounts
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Quality ComplianceInspection ReadinessQMS AssessmentAudit PreparationData AnalysisProject ManagementSupplier ManagementContinuous ImprovementDigital QMS TransformationcGMP
Soft Skills
LeadershipCommunicationProblem-SolvingCollaborationAutonomyPresentation SkillsAdaptabilityRelationship ManagementStrategic ThinkingTactical Leadership