QA Specialist, External Quality

Job description

**Introduction to role:** Are you ready to take ownership of batch disposition and be the final quality gate between outsourced manufacturing and patients who rely on our medicines? Do you thrive on turning complex GMP evidence into clear, timely release decisions that keep supply moving without compromising standards? Based in Dublin, you will join a high-performing External Quality team that partners closely with contract manufacturers and internal stakeholders to secure reliable, compliant supply. Your expertise will ensure every batch we release reflects our commitment to patients and regulators, while your judgment and communication will bring clarity and pace to cross-functional decision-making. **Accountabilities:** - Batch Disposition Leadership: 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. - GMP Compliance Review: Verify alignment with GMP, relevant regulatory guidance, and internal quality standards, applying risk-based thinking to drive sound, defensible decisions. - CMO Quality Partnership: Build strong working relationships with contract manufacturers to resolve discrepancies, clarify expectations, and improve right-first-time performance. - Issue Management and Communication: Triage quality issues, secure effective containment and corrective actions, and provide clear, timely batch status updates to supply chain and stakeholders. - Data Interpretation and Decision Making: Analyze quality data and trends to propose pragmatic solutions for technical or compliance challenges and to inform disposition decisions. - Audit and Inspection Support: Prepare, support, and follow up on audits or inspections related to external manufacturing, ensuring documentation readiness and robust responses. - Continuous Improvement: Identify and drive improvements in external manufacturing quality processes, documentation flow, cycle time, and ways of working. - Cross-Functional Collaboration: Partner with Supply Chain, QA, QC, Technical Operations, and Regulatory teams to protect supply continuity and elevate external network performance. **Essential Skills/Experience:** - 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. **Desirable Skills/Experience:** - Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred; consideration will be given to other relevant experience and education. **Why AstraZeneca:** Join a company where the mission to transform patients’ lives is matched by the way we work: rigorous, collaborative, and grounded in empathy. You will work with unexpected teams in the same room unleashing bold thinking, supported by leaders who value kindness alongside ambition. We combine the pace and autonomy to innovate with the scale to turn great ideas into global impact. In this role, your decisions in external quality directly safeguard a dependable supply of critical therapies, while you grow alongside experts across manufacturing, quality, and supply functions. **Call to Action:** Step into a role where your judgment shapes the release of life-changing medicines and your voice elevates our external network—share your CV and make your impact in Dublin. **Date Posted** 11-Sep-2026 **Closing Date** 21-Sep-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.