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Amgen

GCP Auditor – Global R&D Audit

Amgen

. Plan, conduct and report routine and direct GCP compliance audits internationally .

Posted 9/22/2026full-timeRemote • United StatesSeniorLead💰 $104,725 - $141,687 per yearWebsite

Core Competencies

Role fit
Core Competencies

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Demonstrates expertise in GCP compliance auditing, regulatory inspections, and process improvement initiatives within R&D Quality. Strong ability to identify compliance risks and communicate effectively with management and regulatory authorities.

Highest-signal resume keywords
GCP Compliance AuditingRegulatory Authority InspectionsProcess Improvement InitiativesData AnalyticsExcellent Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills
GCP ComplianceInternational AuditingData MiningData ManipulationScientific DisciplineMedical SciencesPharmacy ExperienceControlled Document DevelopmentRisk IdentificationQuality Management
Soft Skills
Excellent Written CommunicationExcellent Verbal Communication
Certifications & Qualifications
Doctorate DegreeMaster's DegreeBachelor's DegreeAssociate's DegreePostgraduate Qualification
Industry Keywords
R&D QualityCompliance RisksClinical SitesAmgen FacilitiesInternational Travel

About the role

Key responsibilities & impact
  • Plan, conduct and report routine and direct GCP compliance audits internationally
  • Serve as a lead auditor for complex GCP audits
  • Identify and communicate compliance risks to R&D Quality management
  • Host and/or play a role in regulatory authority inspections
  • Contribute to or lead R&D Quality process improvement initiatives
  • Author and contribute to the development of R&D Quality cross functional controlled documents
  • Support regulatory inspections of clinical sites and Amgen facilities

Requirements

What you’ll need
  • Doctorate degree OR
  • Master’s degree and 2 years of scientific discipline, medical sciences or pharmacy experience OR
  • Bachelor’s degree and 4 years of scientific discipline, medical sciences or pharmacy experience OR
  • Associate’s degree and 8 years of scientific discipline, medical sciences or pharmacy experience OR
  • High school diploma / GED and 10 years of scientific discipline, medical sciences or pharmacy experience
  • Postgraduate qualification
  • Participation in process improvement initiatives
  • Extensive experience conducting international auditing in GCP or as a regulatory authority inspector
  • Experience of data mining, manipulation and data analytics would be advantageous
  • Excellent written and verbal communication skills
  • Ability to travel internationally, up to 40%

Benefits

Comp & perks
  • 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
  • Stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible
  • Career development opportunities
  • Financial plans with opportunities to save towards retirement or other goals
  • Work/life balance support