QA, New Product Introduction (NPI) Technical Manager

Location: Dublin – College Park
Company: Alexion, AstraZeneca Rare Disease
Business Area: Operations – Quality
Job Type: Full‑time | Grade C | On‑site (Hybrid – minimum 3 days onsite)

Drive quality excellence as we bring new therapies to patients

At Alexion, part of AstraZeneca’s Rare Disease division, quality is fundamental to everything we do. Our Dublin College Park site plays a critical role in introducing new products, technologies, facilities and processes that enable delivery of life‑changing medicines to patients worldwide.

We are seeking an experienced QA, New Product Introduction (NPI) Technical Manager to provide quality leadership across new product introductions and site improvements. This role ensures that all new products, equipment, systems and processes are implemented in full alignment with cGMP, regulatory and corporate requirements, while supporting a robust and evolving Quality Management System.

What you’ll do

As QA, NPI Technical Manager, you will act as a key quality partner across the site, providing expert QA oversight and guidance during new product introductions and technical change initiatives. You’ll work closely with cross‑functional partners to ensure quality is embedded at every stage—from concept through commercial readiness.

Your responsibilities will include:

• Partnering with Technical Services, Manufacturing, Engineering, Facilities, Validation, QC, Supply Chain, Packing, Warehouse, QPs and QA teams to provide QA leadership and technical direction
• Providing QA oversight for NPIs, new technologies, and new or modified facilities, equipment and processes across manufacturing, packing and analytical areas
• Ensuring compliance with EU, FDA and other regulatory requirements, corporate standards and internal procedures
• Leading risk‑based quality strategies and advising on appropriate control approaches
• Overseeing qualification and validation activities (CQV), including review and approval of protocols and reports for facilities, equipment, utilities, IT systems, analytical methods, process and cleaning validation
• Conducting timely, risk‑based review and approval of GMP documentation such as SOPs, batch records, sampling plans, process descriptions and project documentation
• Supporting quality aspects of new material introductions and ensuring material readiness for GMP use
• Reviewing and approving deviation investigations related to NPI activities and ensuring effective root cause analysis and CAPAs
• Participating in project change control programs for new or modified facilities, equipment, systems and processes
• Implementing and periodically reviewing QA procedures relating to NPIs, validation and associated work areas
• Conducting and supporting quality risk assessments and ensuring quality decisions are well documented and communicated
• Supporting audit readiness and regulatory inspections (internal and external)
• Identifying and driving continuous quality improvement initiatives
• Undertaking additional QA responsibilities as required by site Quality leadership

Essential experience:

Preferred experience:

• Experience within biopharma manufacturing and aseptic processing
• QA experience supporting QC, supplier quality or packing validation
• Strong analytical, auditing and technical writing skills
• Experience using multiple computerised manufacturing and QA systems
• Strong planning and organisational skills with the ability to track and deliver QA commitments
• Adaptability and comfort working in a changing, project‑driven environment
• Excellent interpersonal and communication skills (written and verbal)

Why Alexion?

At Alexion, you’ll be part of a passionate organisation dedicated to transforming the lives of people living with rare diseases. You’ll work in a highly collaborative environment, supporting high‑impact projects and playing a critical role in bringing new therapies to patients—safely, compliantly and efficiently.

Dublin College Park offers a dynamic, modern manufacturing environment, strong investment in new technologies, and meaningful opportunities for professional development within the AstraZeneca family.

Ready to make an impact?

If you are passionate about quality, thrive in technically sophisticated environments, and want to play a key role in new product introductions that truly matter, we would love to hear from you.

Apply today and help ensure every new product meets the highest standards of quality and patient safety.