Senior Quality Specialist, MIA – Hybrid/Remote

Cpl Group; Dublin; Hybrid; EUR 60,000 - 65,000; Full time

Benefits offered by this job

Benefits package

Hybrid work arrangement

Job summary

CPL Group, on behalf of a Dublin-based client, is seeking a Senior Quality Specialist for a permanent hybrid role with 2 on-site days and 3 remote days. You will oversee quality operations for MIA and compounding, ensuring compliance with EU regs and HPRA guidelines while driving continuous improvement to protect patient safety and product integrity.

The role requires collaboration across teams, CAPA management, audit support, and governance of the QMS (ISO 13485) with responsibility for GDP/GMP

Qualifications

• Bachelor’s degree or higher in a relevant field.
• Strong knowledge of GMP, GDP, ISO 13485:2016, ISO 9001:2008 and EU regulations.
• Demonstrated ability in quality systems management.
• Experienced with industry best practices for quality and compliance.
• Experience managing multiple stakeholders; proactive and collaborative.

Responsibilities

• Quality Compliance & Regulatory Oversight in line with EU regulations and HPRA GDP/GMP.
• Oversee MIA activities for Parental Nutritional PN products and SAP disposition.
• Coordinate CAPA investigations and manage stability testing data.
• Lead audits, inspection readiness, and corrective actions with owners.
• Maintain ISO 13485 QMS and ensure annual product review for MIA products.
• Coordinate internal audits and change controls, ensuring closure and effectiveness.

Skills

Quality management

Regulatory knowledge

Cross-functional collaboration

Problem solving

Education

Bachelor's degree or higher

Tools

SAP

Job description

CPL Group, on behalf of a Dublin-based client, is seeking a Senior Quality Specialist for a permanent hybrid role with 2 on-site days and 3 remote days. You will oversee quality operations for MIA and compounding, ensuring compliance with EU regs and HPRA guidelines while driving continuous improvement to protect patient safety and product integrity.

The role requires collaboration across teams, CAPA management, audit support, and governance of the QMS (ISO 13485) with responsibility for GDP/GMP