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Regeneron

Senior Manager, QA Auditor, GCP Strategy

Regeneron

Senior Manager leading GCP Audit Strategy at Regeneron. Overseeing compliance across therapeutic areas and collaborating with global teams in a remote role.

Posted 7/2/2026full-timeRemote • 🇬🇧 United KingdomSeniorWebsite

Tech Stack

Tools & technologies
Google Cloud Platform

About the role

Key responsibilities & impact
  • Lead risk-based audit planning across therapeutic areas and studies
  • Drive strategic audit programs using risk indicators from study teams
  • Ensure audits align with approved programs and scheduled timelines
  • Manage audit outcomes to identify trends and communicate risks
  • Represent quality assurance on complex cross-functional initiatives
  • Deliver reports and metrics to Global Development leadership
  • Collaborate effectively with stakeholders across global functions
  • Navigate ambiguity while prioritizing multiple complex activities

Requirements

What you’ll need
  • Bachelor’s degree with 8+ years of relevant industry experience
  • 5+ years of GCP audit strategy or audit experience
  • Knowledge of FDA, EU, and ICH GCP regulations and guidance
  • Experience supporting or participating in regulatory inspections
  • Strong project management and stakeholder management capabilities
  • Excellent written and verbal communication skills with senior audiences.

Benefits

Comp & perks
  • annual bonuses or other incentive plans
  • equity awards
  • pension or retirement benefits
  • 401(k) company match
  • health and wellness programs
  • fitness centers
  • insurance benefits (e.g. medical, dental, vision, life and disability)
  • paid time off
  • family support benefits

ATS Keywords

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Applicant Tracking System Keywords

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

Hard Skills & Tools
Audit PlanningRisk Indicators AnalysisTrend IdentificationQuality AssuranceReport DeliveryMetrics DevelopmentRegulatory ComplianceGCP Regulations KnowledgeFDA Regulations KnowledgeICH Guidelines Knowledge
Soft Skills
Excellent Communication SkillsCollaborationNavigating AmbiguityPrioritizationStakeholder Engagement