Quality Specialist

Help shape quality where patients depend on it most

At LEO Pharma Cork, quality is more than compliance - it is how we protect patients, strengthen trust and ensure that critical medicines are delivered with confidence. As our new Quality Specialist, you will play a central role in supporting API Manufacturing, driving thorough assessment of regulatory, validation, patient safety and product impact', robust quality processes and ensuring investigations are handled with precision, clarity and impact.

At LEO Pharma, we are global leaders in medical dermatology and Critical Care, with 117 years of experience in bringing innovation to healthcare. Each year, close to 100 million people have a better day because of our medicines.

In Cork, you will join a site with a clear purpose: supporting high-risk patient groups and critical-care conditions through high-quality medicines and continuous improvement.

Your Role

As our new Quality Specialist, you will provide essential site support to ensure compliance with the LEO Quality Management Systen, cGMP and applicable regulatory requirements. You will support batch release activities, strengthen quality documentation and play a key role in Deviations, Change Controls and Laboratory Investigations - ensuring issues are understood, communicated and resolved effectively.

This is a broad and influential role where technical quality expertise, structured thinking and clear, confident communication are equally important.

Your key responsibilities will include:

• Ensuring batch release and associated activities are conducted in line with internal procedures, cGMP and the LEO Quality Management System.
• Reviewing, approving and authorising quality documentation, including batch records, worksheets, deviations, CAPAs, change controls, validation documentation and laboratory investigations.
• Supporting root cause analysis and CAPA definition in collaboration with relevant stakeholders.
• Releasing or rejecting APIs and intermediates in accordance with applicable requirements.
• Driving quality improvements, harmonisation and simplification of procedures across API Quality and Global Quality.

You will also compile quality metrics, support supplier audit information requests, contribute to Annual Product Quality Reviews, provide GMP induction training and work with systems such as Veeva Vault, PowerBI, MyDoc and SAP.

A key part of your success will be your ability to release batches within the allowed lead time and approve Quality records within the lead times assigned to the Quality Release and Support department, communicate investigation outcomes, quality risks and required actions clearly and confidently across functions.

Your Qualifications

To succeed in this role, you will bring a strong quality background, solid GMP knowledge and hands-on experience in a regulated pharmaceutical environment. Experience with laboratory investigations, deviation management and cross-functional quality communication will be especially important.

We are looking for someone with:

• A third-level qualification in a relevant scientific discipline, supported by relevant pharmaceutical industry experience.
• Deep knowledge of cGMP, including EU GMP Volume 4 Parts I and II, relevant annexes, and 21 CFR Parts 210, 211 and Part 11.
• Experience with laboratory investigations, deviation management, and Change Controls, SOPs, investigations and validation documentation.
• Practical understanding of API manufacturing, batch release, laboratory investigations and quality systems.
• Experience using quality and business systems such as Veeva Vault, PowerBI, MyDoc and SAP would be an advantage.

As a person, you bring an inherent quality mindset, attention to detail and a strong sense of accountability. You are comfortable asking the right questions, challenging constructively and communicating complex quality matters in a clear, confident and collaborative way.

Your New Team

You will join the Quality team at LEO Pharma Cork, reporting to the Associate Quality Manager. Working closely with API Manufacturing, Global Quality, laboratory teams and other site functions, you will help ensure quality decisions are made with integrity and supported by strong investigation processes. The team shares a “challenge accepted” mindset and is guided by simplification, collaboration and accountability.

Your Application

You do not need to upload a cover letter, but feel free to add a few sentences in your CV on why this position has your interest. Please refrain from including a photograph or images.