QA Disposition Lead - External Manufacturing

Alexion Pharma Spain S.L.; Dublin; Hybrid; EUR 80,000 - 110,000; Full time

Job summary

AstraZeneca in Dublin seeks an experienced professional to own batch disposition for externally manufactured products, ensuring compliant and timely releases. You will lead end-to-end review, navigate GMP standards, and coordinate with CMOs and internal teams to safeguard patient supply.

The role emphasizes data-driven decision making, audit support, and continuous improvement within a fast-paced, regulated biopharma environment in Ireland.

Qualifications

• Experience with drug substance, drug product, and finished product manufacturing in a cGMP environment.
• Knowledge of industry best practices and regulatory expectations for biopharma manufacturing.
• 2–5 years GMP-related experience in biopharma/pharma.
• Experience working with contract manufacturing organizations.
• Strong written and verbal communication and negotiation skills.
• Ability to prioritize and manage fast-paced tasks with defined procedures.

Responsibilities

• Lead end-to-end batch disposition of externally manufactured products.
• Verify GMP compliance and regulatory alignment for releases.
• Maintain strong relationships with CMOs to resolve issues.
• Triage quality issues and provide timely batch status updates.
• Analyze quality data to support disposition decisions.
• Support audits and inspections with thorough documentation.
• Drive continuous improvement in external manufacturing processes.
• Collaborate cross-functionally to protect supply continuity.

Skills

GMP experience

Contract manufacturing

Excellent communication

Decision making

Data interpretation

Cross-functional collaboration

Education

Bachelor’s degree

Job description

AstraZeneca in Dublin seeks an experienced professional to own batch disposition for externally manufactured products, ensuring compliant and timely releases. You will lead end-to-end review, navigate GMP standards, and coordinate with CMOs and internal teams to safeguard patient supply.

The role emphasizes data-driven decision making, audit support, and continuous improvement within a fast-paced, regulated biopharma environment in Ireland.