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Senior Manager, Quality Assurance - GxP

PTC Therapeutics · Dublin, County Dublin, Ireland

Location
Dublin
Job Type
Full time
Posted
June 28, 2026

Job Description

Job Description:

Responsibilities for the role include:

The incumbent works cross-functionally with internal departments and external resources on GxP QA related issues. 

The Senior Manager, Quality Assurance – GxP supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs), as appropriate.

  • Contributes to and executes PTC’s GxP risk-based audit strategy to achieve compliance with applicable current regulatory requirements.
  • Performs internal and external audits as assigned to ensure compliance with GMP and GDP regulations (may include internal processes, Contract Manufacturing Organizations (CMOs), laboratories distributors, and other vendors).Communicates audit results to stakeholders and writes audit report.Assesses audit responses and ensures closure of corrective and preventative actions (CAPAs).
  • Leads backroom activities during regulatory authority inspections and assists w...

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