Batch Disposition Lead — External QA (GMP)

Biopharma Careers; Blanchardstown; On-site; EUR 90,000 - 120,000; Full time

Job summary

AstraZeneca in Dublin seeks a senior External Quality professional to own batch disposition for externally manufactured products. You will lead end-to-end reviews, verify GMP compliance, and partner with contract manufacturers to resolve issues and improve compliance.

You will analyze quality data to support timely decisions, contribute to audits, and drive continuous improvements across the external manufacturing network.

Qualifications

• Must have experience/knowledge of drug substance, drug product and finished product manufacturing processes in a cGMP environment.
• Experience working with contract manufacturing organisations.
• Excellent written and verbal communication and negotiating skills.
• Ability to prioritize and make timely decisions in a fast-paced environment.

Responsibilities

• Batch Disposition Leadership: lead end-to-end review and disposition of externally manufactured batches.
• GMP Compliance Review: verify alignment with GMP and regulatory guidance.
• CMO Quality Partnership: build strong relationships with contract manufacturers.
• Issue Management: triage quality issues and provide timely batch status updates.
• Data Interpretation: analyze quality data to inform disposition decisions.
• Audit Support: prepare and follow up on external manufacturing audits or inspections.
• Continuous Improvement: identify improvements in external manufacturing quality processes.

Skills

Batch disposition

GMP compliance

Data analysis

Communication

Cross-functional collaboration

Education

Bachelor's degree

Job description

AstraZeneca in Dublin seeks a senior External Quality professional to own batch disposition for externally manufactured products. You will lead end-to-end reviews, verify GMP compliance, and partner with contract manufacturers to resolve issues and improve compliance.

You will analyze quality data to support timely decisions, contribute to audits, and drive continuous improvements across the external manufacturing network.