QA QRM Lead

HERO Recruitment Ltd.; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

HERO Recruitment Ltd. seeks a QRM Lead to establish and embed a risk-based quality management program for a new digitally enabled biologics facility. The role covers start-up, operations, automation, data flows and paperless manufacturing continuity.

As the project QRM subject-matter expert, you will ensure quality risk management is applied, risk assessments are facilitated, and decisions are science-based and inspection-ready in collaboration with Quality, IT, Automation and Engineering.

Qualifications

• Extensive QRM experience in GMP/pharma or biologics manufacturing.
• Strong knowledge of ICH Q9(R1) and digital manufacturing.
• Ability to influence site design, operating models and quality governance.
• Experience managing resilience, data integrity in digital environments.

Responsibilities

• Establish and manage facility QRM program in accordance with regulations.
• Select appropriate risk assessment methods and facilitate assessments.
• Embed risk-based decision-making across facility start-up, manufacturing, automation and data flows.
• Ensure risk decisions are science-based, documented and inspection-ready.
• Partner with Quality, Manufacturing, IT, Automation and Engineering to identify, mitigate 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

ICH Q9 knowledge

Digital manufacturing

Quality governance

Data integrity

Operational resilience

Risk-based decisions

Job description

QRM Lead – Digital Core Implementation

Department: Quality Assurance

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.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Establish and manage the facility QRM program in accordance with applicable regulations, ICH Q9(R1) and internal procedures.
• Select appropriate risk assessment methods and facilitate the completion, periodic review and communication of risk assessments.
• Embed risk-based decision-making across facility 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, mitigate and assign ownership of risks.
• Develop and maintain the risk management plan for digital and corporate systems, including DCS, MES, eBR, ERP, data historians and network infrastructure.
• Support project quality and business objectives relating to GxP risk management.

Education and experience:

• Extensive QRM experience in GMP-regulated pharmaceutical or biologics manufacturing, including use of multiple risk assessment methods and facilitation of complex risk assessments.
• Strong knowledge of ICH Q9(R1), digital manufacturing and system-enabled operations.
• Demonstrated ability to influence site design, operating models and quality governance.
• Experience managing operational resilience, data integrity and business continuity risks in digital or paperless environmentss.