We are seeking a **Senior Specialist (QRM & Auditing)** to play a key role within our **Global Development Quality Assurance** team at our BioNX R&D facility in Dunboyne. In this role, you will lead the site’s Quality Risk Management and Auditing programmes, help shape a culture of continuous improvement, and mentor more junior QA colleagues.- Ensure compliance with global and regulatory QMS requirements, including: * Quality Manual * Change Control * Deviation Management * Supplier Quality Management * Quality Risk Management * Audit Management and associated electronic systems* Participate in global and local Communities of Practice for QRM and Auditing* Work collaboratively with cross‐functional partners to drive a safe, compliant and proactive quality culture in BioNX* Perform additional duties as assigned by your manager/supervisor* At least **5 years of experience** in a GMP environment within pharma/biotech, ideally in a QA, QRM or auditing role* Solid understanding of Quality Risk Management, audit processes, and inspection readiness* Experience working with quality systems (e.g., deviations, change control, CAPA, supplier quality) and associated electronic tools* Ability to interpret and apply global and regulatory quality requirements* Proven ability to influence, train and mentor others* Strong communication, stakeholder management and collaboration skills
#J-18808-Ljbffr