Senior Manager GD GCP Auditing (Ireland)

Regeneron Pharmaceuticals
Ireland
Full Time
Remote
Senior
EUR 86,800 – 141,200
Bachelor Degree
Healthcare Healthcare Life Sciences

Posted 1 month ago

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Excellent 4.7

Job summary

The Senior Manager GD GCP Auditing at Regeneron leads quality audits supporting global development, ensuring compliance with GCP, FDA, EU, and ICH standards. The role involves planning, conducting, and reporting audits, managing compliance issues, and supporting regulatory inspections in a remote work environment in Ireland.

Responsibilities

The Senior Manager will lead end-to-end risk-based GCP auditing activities and ensure compliance across internal and external global development programs. They will also represent Quality Assurance in complex compliance initiatives and support regulatory inspection activities.

Qualifications

audit planning European Union regulations FDA regulations GCP auditing GCP requirements GxP compliance ICH guidance regulatory inspections risk-based auditing stakeholder management

Candidates must possess a Bachelor's degree and at least 8 years of industry experience, including 5 years of direct GCP audit experience. Expert knowledge of FDA, EU regulations, and ICH guidance is required, along with strong leadership and project management capabilities.

English

Benefits

  • Annual bonuses
  • Incentive plans
  • Equity awards
  • Pension benefits
  • Retirement benefits
  • Health and wellness programs
  • Fitness centers
  • Insurance benefits
  • Paid time off
  • Family support benefits

Company

Regeneron Pharmaceuticals

Regeneron Pharmaceuticals

linkedin
Biotechnology
Location
Ireland

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Excellent 4.7
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