Senior Specialist External Quality

Senior Specialist External Quality

Location: Dublin, Athlone or Cork, Ireland

Help shape the future of medicines through quality excellence

We're looking for a Senior Specialist External Quality to join our team and play a critical role in supporting the transfer and manufacture of innovative medicines through our global network of Contract Manufacturing Organisations (CMOs).

In this highly visible role, you'll partner with Product Development, Clinical Supply, Manufacturing, and External Supply teams to ensure quality is embedded throughout the technical transfer process for both clinical and commercial products. You'll provide quality leadership, help drive compliance and continuous improvement, and work collaboratively with internal and external stakeholders to ensure successful delivery of key milestones.

This is an excellent opportunity for a quality professional who enjoys working across complex projects, influencing stakeholders, and making a real impact on patient supply.

What you'll be doing

• Acting as the quality lead across technical transfer projects, partnering closely with Product Development, Clinical Supply, External Manufacturing and Supply Chain teams.
• Providing quality oversight of Drug Substance and Drug Product activities performed by CMOs.
• Reviewing and approving key quality documentation including batch records, deviations, CAPAs, change controls and quality investigations.
• Supporting GMP compliance, risk assessments and continuous improvement initiatives across external manufacturing operations.
• Driving quality metrics, trend analysis and performance monitoring to identify opportunities for improvement and risk mitigation.
• Supporting technical transfer activities from clinical through commercial manufacture, ensuring quality requirements are met at every stage.
• Participating in audits and inspections, including supporting regulatory agency interactions where required.
• Guiding colleagues on quality systems, compliance expectations and best practices.
• Support the implementation and adoption of digital quality solutions and AI-enabled technologies to enhance quality oversight, compliance, operational efficiency, and data-driven decision-making.

What we're looking for

Essential

• BSc degree in Biological Sciences, Chemical Sciences, Pharmaceutical Sciences or a related discipline or equivalent experience.
• Significant experience within Quality Assurance in a GMP-regulated pharmaceutical, biotech or biopharmaceutical environment.
• Experience supporting technical transfer activities across Drug Substance and/or Drug Product manufacturing.
• Strong understanding of quality management systems, GMP requirements and pharmaceutical manufacturing processes.
• Experience reviewing and approving quality documentation including deviations, CAPAs and change controls.
• Experience working with Contract Manufacturing Organisations (CMOs) and external partners.
• Strong problem-solving skills with the ability to make sound, risk-based decisions.
• Excellent stakeholder management and communication skills, with the ability to influence across functions and organisational levels.
• Ability to analyse data, identify trends and recommend improvements.
• Flexibility to travel as required.

Preferred

• Experience supporting biologics technical transfers from clinical development through commercial manufacture.
• Experience working with clinical-stage products.
• Experience supporting engineering, validation and PPQ activities.
• Knowledge of FDA, EMA, HPRA and PMDA regulatory requirements.
• Experience leading quality-related projects, business improvements or change initiatives.
• Strong project management skills.

Why join us?

You'll be joining a collaborative and innovative environment where quality is at the heart of everything we do. This role offers the opportunity to work on complex global projects, build strong partnerships across a diverse stakeholder group, and help ensure that life-changing medicines reach patients around the world.

If you're passionate about quality, continuous improvement and delivering excellence in pharmaceutical manufacturing, we'd love to hear from you.

Date Posted

16-Sept-2026

Closing Date

30-Sept-2026

Our 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.