Quality Systems Specialist: Drive Compliance&Impact, Huntstown

Job Description Our Biotech facility in Dublin began construction in 2018 and has progressed at an impressive rate since then. The site plays a pivotal role in the manufacture of our Company’s biologics-based medicines, including immuno‑oncology, and it has expanded our Company’s current internal network of biologics drug substance manufacturing plants since full manufacturing operations began in 2021.

The Quality Systems Specialist is responsible for maintaining and continuously improving the quality management system throughout their knowledge and areas of expertise. They ensure that objectives are effectively achieved, consistent with site requirements, to ensure compliance, safety and reliable supply to our customers.

Responsibilities

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

Manage change control and internal auditing.

Provide run‑the‑business support for critical quality systems to ensure continued sustainable compliance.

Support management of the Global Change Management process at the site and drive best practices.

Ensure the health and wellbeing of the quality management system at the site, ensuring timely actions are taken to meet compliance&production needs.

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

Oversee the quarterly deviation trending process by cross‑functional area owners on a routine basis and be responsible for completion of annual trending at the site.

Support management of site manufacturing licence(s) compliance and associated activities.

Support regulatory and divisional audit inspections at the site as required.

Support management of recalls as required.

Comply with site global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in day‑to‑day activities and all applicable job functions.

Build a quality culture that delivers unconstrained supply, right‑first‑time to our patients.

Qualifications

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

5 years’ experience in Quality Control, Quality Assurance or pharmaceutical, vaccine or biological operations or technical operations.

Excellent knowledge of relevant quality and compliance guidelines (cGMP, auditing, quality management systems, quality agreements, regulatory affairs, training) and respective regulations.

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

Desire to continuously learn, improve and develop, and motivation to be an inspiring member of a high‑performing team.

Excellent communicator, decisive decision maker, willingness to support the team and proven ability to deliver excellence.

Equal Opportunity Statement As an equal opportunity employer, we are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.

Requisition ID: R398055

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