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:

Third‑level qualification (e.g. B.Sc. in Science or Pharmacy) or equivalent
Ideally 6–8 years’ experience in a cGMP Biotech Quality Assurance environment
Strong working knowledge of cGMP requirements for bio/pharmaceutical manufacturing, packing, analytical testing and storage
Experience supporting new product introductions, technical transfer and CQV activities
Demonstrated ability to provide QA oversight across complex, cross‑functional projects
High levels of accuracy, attention to detail and ownership
Self‑motivated with strong energy and eagerness to learn

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.

Date Posted

28-Apr-2026

Closing Date

11-May-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.

QA, New Product Introduction (NPI) Technical Manager

Benefits

Job Description