QA Disposition Lead: External Manufacturing & Compliance

AstraZeneca; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

AstraZeneca in Dublin is seeking a Senior External Quality professional to own batch disposition and act as the final quality gate between outsourced manufacturing and patients. You will drive end-to-end review of externally manufactured batches, ensuring records, investigations and certificates of analysis support timely, compliant release.

You will partner with contract manufacturers and cross-functional teams to uphold GMP standards, provide clear disposition decisions, and continuously

Qualifications

• Must have experience/knowledge of drug substance, drug product and finished product manufacturing processes in a cGMP environment.
• Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
• Minimum of 2-5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industry
• Experience working with contract manufacturing organisations
• Excellent written and verbal communication and negotiating skills
• Ability to exercise judgment with defined procedures and practices to determine appropriate action
• Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
• Ability to monitor and report on assigned tasks, goals, and objectives.

Responsibilities

• Lead end-to-end review and disposition of externally manufactured batches, including batch records, deviations, investigations, certificates of analysis, and change controls, to achieve compliant and timely release.
• Verify alignment with GMP, relevant regulatory guidance, and internal quality standards, applying risk-based thinking to drive sound, defensible decisions.
• Build strong working relationships with contract manufacturers to resolve discrepancies, clarify expectations, and improve right-first-time performance.
• Triage quality issues, secure effective containment and corrective actions, and provide clear, timely batch status updates to supply chain and stakeholders.
• Analyze quality data and trends to propose pragmatic solutions for technical or compliance challenges and to inform disposition decisions.
• Prepare, support, and follow up on audits or inspections related to external manufacturing, ensuring documentation readiness and robust responses.
• Identify and drive improvements in external manufacturing quality processes, documentation flow, cycle time, and ways of working.
• Partner with Supply Chain, QA, QC, Technical Operations, and Regulatory teams to protect supply continuity and elevate external network performance.

Skills

GMP knowledge

Contract manufacturing experience

Communication skills

Prioritization / time management

Data interpretation

Education

Bachelor’s degree

Advanced degree preferred

Job description

AstraZeneca in Dublin is seeking a Senior External Quality professional to own batch disposition and act as the final quality gate between outsourced manufacturing and patients. You will drive end-to-end review of externally manufactured batches, ensuring records, investigations and certificates of analysis support timely, compliant release.

You will partner with contract manufacturers and cross-functional teams to uphold GMP standards, provide clear disposition decisions, and continuously