Quality Systems Specialist, Huntstown

Quality Systems Specialist– Dublin, Ireland Our Biotech facility in Dublin, under construction since 2018, plays a pivotal role in the manufacture of our company’s biologics-based medicines, including immuno-oncology. It supports full manufacturing operations that began in 2021 and expands our biologics drug substance manufacturing network.

Responsibilities

Provide quality support to the project and site, including training and guidance on interpretation and implementation of site guidelines, policies and regulatory requirements.

Manage change control, internal audits and run‑the‑business support for critical quality systems to ensure sustainable compliance.

Support management of the global change management process at the site and drive best practices.

Maintain the health and well‑being of the quality management system to meet compliance and production needs.

Support metrics management for site change control and internal audit systems.

Oversee quarterly deviation trending and annual trending at the site.

Assist in managing site manufacturing licence compliance and related activities.

Provide support for regulatory and divisional audit inspections as required.

Assist with recall management, as required.

Ensure adherence to cGMP and other global and regulatory requirements in all day‑to‑day activities.

Build a quality culture that delivers unconstrained supply and right‑first‑time delivery to patients.

Qualifications

Bachelor’s or Master’s degree in Biological Sciences or equivalent.

Minimum 5 years’ experience in Quality Control, Quality Assurance, or pharmaceutical, vaccine or biologic operations.

Excellent knowledge of cGMP, auditing, quality management systems, quality agreements, regulatory affairs, and training.

Experience with new product introductions and/or process qualification/technology transfer.

Desire to continuously learn, improve and develop, and motivation to inspire in a high‑performing team.

Excellent communicator, decisive decision maker, and proven ability to deliver excellence.

We are an equal‑opportunity employer that embraces diversity and commitment across all roles. Applicants are encouraged to apply before 05/28/2026.

Requisition ID: R398055

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