Quality Risk Management Lead - Digital Manufacturing

Cpl Group; Munster; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

CPL Group seeks an experienced QRM Lead to support a digitally enabled manufacturing environment for a leading biopharma site in Ireland. You will establish and embed risk-based quality principles across manufacturing operations, digital systems, automation, and governance.

Lead risk assessments, partner with Quality, Manufacturing, Engineering, Automation and IT to manage operational and compliance risks, and drive risk-based decisions across the site lifecycle.

Qualifications

• Degree in Science, Engineering, Quality, Pharmaceutical Sciences or related discipline.
• 8+ years' experience in QA, Quality Systems, Validation, Compliance or Quality Risk Management in pharma/biotech.
• Strong knowledge of ICH Q9(R1) Quality Risk Management principles.
• Experience leading risk-based quality initiatives in GMP environments.
• Experience with MES, eBR, DCS, ERP, CSV or Data Integrity programmes.
• Excellent stakeholder management and communication skills.
• Ability to influence decision-making across Quality, Manufacturing, Automation and Engineering.

Responsibilities

• Lead the implementation and ongoing management of the site QRM programme.
• Facilitate complex risk assessments using methods like FMEA and risk ranking.
• Embed risk‑based decision making across manufacturing, automation, quality systems and start‑up activities.
• Partner with Quality, Manufacturing, Engineering, Automation and IT to mitigate risks.
• Develop risk management strategies for digital manufacturing and critical systems.
• Assess risks with MES, eBR, DCS, ERP, data historians and supporting infrastructure.
• Support data integrity and paperless manufacturing initiatives.
• Ensure quality risk decisions are justified and inspection-ready.
• Provide QRM input during audits, inspections and major project reviews.

Skills

QRM leadership

Cross-functional collaboration

Stakeholder management

Quality systems understanding

Communication skills

Problem solving

Education

Degree in Science/Engineering/Quality/Pharmaceutical Sciences

Tools

PAS-X

Syncade

DeltaV

PI Historian

SAP

Job description

CPL Group seeks an experienced QRM Lead to support a digitally enabled manufacturing environment for a leading biopharma site in Ireland. You will establish and embed risk-based quality principles across manufacturing operations, digital systems, automation, and governance.

Lead risk assessments, partner with Quality, Manufacturing, Engineering, Automation and IT to manage operational and compliance risks, and drive risk-based decisions across the site lifecycle.