Qa, New Product Introduction (npi) Technical Manager

Alexion, AstraZeneca Rare Disease

Dublin, Ireland
3 days onsite
Cgmp compliance knowledge
New product introduction oversight
Cqv protocol review and approval
Alexion, part of AstraZeneca's Rare Disease division, is seeking a QA, New Product Introduction (NPI) Technical Manager in Dublin, Ireland. The role involves providing quality leadership for new product introductions, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to maintain high-quality standards in the biopharmaceutical industry

Job Summary

  • This role provides critical quality leadership across new product introductions and site improvements to ensure life-changing medicines reach patients safely.
  • The successful candidate will partner with cross-functional teams including Engineering, QC, and Supply Chain to embed quality from concept through commercial readiness.
  • Alexion offers a dynamic, modern manufacturing environment with strong investment in new technologies and meaningful opportunities for professional development within the AstraZeneca family.

Matching Summary

Match Score: 85

Alexion, part of AstraZeneca's Rare Disease division, is seeking a QA, New Product Introduction (NPI) Technical Manager in Dublin, Ireland. The role involves providing quality leadership for new product introductions, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to maintain high-quality standards in the biopharmaceutical industry.

Skills & Requirements

Must-have

  • cGMP compliance knowledge
  • New Product Introduction oversight
  • CQV protocol review and approval
  • Risk-based quality strategies
  • Cross-functional project leadership

Nice-to-have

  • Aseptic processing experience
  • Supplier quality QA background
  • Strong analytical auditing skills
  • Adaptability to changing projects
  • Excellent interpersonal communication

Key Requirements

  • Third-level qualification in Science or Pharmacy
  • 6-8 years cGMP Biotech Quality Assurance experience
  • Experience supporting new product introductions and technical transfer

Work Rights

Not specified

Tailored Resume

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