QA Specialist - External Manufacturing & Batch Release

Alexion Pharmaceuticals, Inc.; Dublin; On-site; EUR 90,000 - 120,000; Full time

Job summary

Alexion Pharmaceuticals, Inc. in Dublin is seeking an experienced professional to own batch disposition and act as the final quality gate between outsourced manufacturing and patients.

You will lead end‑to‑end review of externally manufactured batches, ensuring GMP compliance and driving timely release decisions to secure supply. The role requires strong data interpretation and communication, with 2–5 years of GMP experience in biopharma or related industries and familiarity with contract

Qualifications

• Experience with drug substance, drug product and finished product in a cGMP environment.
• Experience working with contract manufacturers.
• Strong written and verbal communication and negotiation skills.

Responsibilities

• Lead end-to-end review and disposition of externally manufactured batches.
• Verify GMP compliance and advise on risk-based decisions.
• Foster relationships with contract manufacturers to resolve discrepancies.
• Triage quality issues and provide timely batch status updates.
• Analyze quality data to inform disposition decisions and improve processes.
• Support audits/inspections and respond with robust documentation.
• Drive continuous improvements in external manufacturing quality processes.

Skills

Batch disposition leadership

GMP knowledge

CMO collaboration

Data interpretation

Communication skills

Education

Bachelor’s degree

Job description

Alexion Pharmaceuticals, Inc. in Dublin is seeking an experienced professional to own batch disposition and act as the final quality gate between outsourced manufacturing and patients.

You will lead end‑to‑end review of externally manufactured batches, ensuring GMP compliance and driving timely release decisions to secure supply. The role requires strong data interpretation and communication, with 2–5 years of GMP experience in biopharma or related industries and familiarity with contract