QRM Lead – Digital Core & Quality Governance

Hero Recruitment Group; Limerick; Hybrid; EUR 90,000 - 140,000; Full time

Job summary

The QRM Lead will establish and embed a risk-based quality management program for a new digitally enabled biologics manufacturing facility. As the project QRM subject-matter expert, they will ensure that quality risk management is systematically applied across facility start-up, operational resilience, digital system dependency, and paperless manufacturing continuity.

Key collaboration with Quality, Manufacturing, IT, Automation and Engineering to identify, mitigate and assign ownership of

Qualifications

• Extensive QRM experience in GMP-regulated pharmaceutical or biologics manufacturing.
• Knowledge of ICH Q9(R1), digital manufacturing and system-enabled operations.
• Ability to influence site design, operating models and quality governance.
• Experience managing operational resilience, data integrity and business continuity risks in digital or paperless environments.

Responsibilities

• Establish and manage the facility QRM program in accordance with regulations.
• Select risk assessment methods and facilitate risk assessments.
• Embed risk-based decision-making across start-up, manufacturing, automation, data flows and quality oversight.
• Ensure risk decisions are science-based, documented and inspection-ready.
• Partner with Quality, Manufacturing, IT, Automation and Engineering to identify and assign ownership of risks.
• Develop and maintain the risk management plan for digital and corporate systems.
• Support project quality and business objectives relating to GxP risk management.

Skills

QRM Expertise

GxP Compliance

Regulatory Knowledge

Job description

The QRM Lead will establish and embed a risk-based quality management program for a new digitally enabled biologics manufacturing facility. As the project QRM subject-matter expert, they will ensure that quality risk management is systematically applied across facility start-up, operational resilience, digital system dependency, and paperless manufacturing continuity.

Key collaboration with Quality, Manufacturing, IT, Automation and Engineering to identify, mitigate and assign ownership of