Senior Manager, QA Auditor, GCP Strategy

QA EngineerQA EngineerFull TimeRemoteSeniorTeam 10,001+Since 1988H1B SponsorCompany SiteLinkedIn

Location

Ireland

Posted

5 days ago

Salary

€86.8K - €141.2K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Manager, QA Auditor, GCP Strategy

Regeneron

• 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 • 10-20% travel might be required

Job Requirements

  • 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

  • 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

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