Batch Disposition Lead – External Quality & Compliance

AstraZeneca GmbH

Dublin

On-site

EUR 65,000 - 90,000

Full time

2 days ago
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Job summary

AstraZeneca GmbH in Dublin seeks a senior External Quality professional to own batch disposition for externally manufactured products, ensuring timely, compliant release decisions in line with GMP and regulatory expectations.

You will partner with contract manufacturers and internal teams to interpret data, manage deviations and inspections, and drive continuous improvement in external manufacturing quality processes.

Qualifications

  • Experience in drug substance, drug product and finished product manufacturing within a cGMP environment.
  • Experience working with contract manufacturing organisations.
  • Excellent written and verbal communication and negotiation skills.

Responsibilities

  • Lead end-to-end batch disposition for externally manufactured batches, including review of records, deviations and change controls.
  • Verify GMP/regulatory alignment and apply risk-based thinking to support defensible disposition decisions.
  • Build strong partnerships with contract manufacturers to resolve issues and improve right-first-time performance.
  • Triage quality issues, contain actions, and provide clear batch status updates to supply chain.

Skills

GMP knowledge
Contract manufacturing
Communication skills
Risk assessment
Data interpretation
Audit support
Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

AstraZeneca GmbH in Dublin seeks a senior External Quality professional to own batch disposition for externally manufactured products, ensuring timely, compliant release decisions in line with GMP and regulatory expectations.

You will partner with contract manufacturers and internal teams to interpret data, manage deviations and inspections, and drive continuous improvement in external manufacturing quality processes.

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