Senior Quality Complaints Specialist

Takeda

Dublin, Ireland
Hybrid
Product quality complaints end-to-end
Complaint handling compliance
Assess patient safety impact
Manage product quality complaints end-to-end, from intake and initiation through investigation, approval, and closure

Job Summary

  • Manage product quality complaints end-to-end, from intake and initiation through investigation, approval, and closure.
  • Act as the quality SME and primary point of contact for commercial product complaints, post-market vigilance monitoring, and inspection support.
  • Takeda offers employer-funded private medical insurance with dependants’ cover, competitive salary and performance-based bonus, and employer retirement plan contributions.

Matching Summary

Manage product quality complaints end-to-end, from intake and initiation through investigation, approval, and closure.

Skills & Requirements

Must-have

  • Product quality complaints end-to-end
  • Complaint handling compliance
  • Assess patient safety impact
  • Cross-functional investigation coordination
  • Subject matter expert for complaints

Nice-to-have

  • Patient-oriented and innovation-driven
  • Continuous improvement mindset
  • Structured risk-based approach
  • Develop and mentor others

Key Requirements

  • Bachelor’s degree and 5–9 years of experience
  • Quality Assurance or GMP-related role
  • Medical device, biotech, or pharma manufacturing experience
  • cGMP and regulatory requirements knowledge
  • EU and FDA complaint reporting understanding
  • Combination product manufacturing knowledge

Work Rights

Not specified

Tailored Resume

Cover Letter