Quality Risk Management Lead

Cpl Group; Munster; On-site; 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

Role: QRM Lead - Digital Core Implementation

Location: Raheen, Limerick (Onsite / Hybrid)

Type: 12-Month Initial Contract Immediate and January start dates will be considered.

Role Overview

At CPL we are supporting a large multinational Pharma company that are seeking an experienced Quality Risk Management (QRM) Lead to support the implementation of a digitally enabled manufacturing environment within a leading biopharmaceutical facility.

This position will act as the Quality Risk Management subject matter expert, establishing and embedding risk-based quality principles across manufacturing operations, digital systems, automation platforms and quality governance processes.

The successful candidate will work cross-functionally with Quality, Manufacturing, Engineering, Automation and IT teams to ensure risks are effectively identified, assessed and mitigated throughout the facility lifecycle.

Key Responsibilities

• Lead the implementation and ongoing management of the site Quality Risk Management (QRM) programme
• Facilitate complex risk assessments using appropriate methodologies including FMEA and risk-ranking approaches
• Embed risk-based decision making across manufacturing, automation, quality systems and facility start-up activities
• Partner with Quality, Manufacturing, Engineering, Automation and IT teams to identify and mitigate operational and compliance risks
• Develop and maintain risk management strategies for digital manufacturing and business-critical systems
• Assess risks associated with MES, eBR, DCS, ERP platforms, data historians and supporting infrastructure
• Support operational resilience, business continuity and data integrity initiatives within a paperless manufacturing environment
• Ensure quality risk decisions are scientifically justified, documented and inspection-ready
• Support change controls, investigations and quality impact assessments from a risk management perspective
• Provide QRM expertise during internal audits, regulatory inspections and major project reviews

Essential Requirements

• Degree in Science, Engineering, Quality, Pharmaceutical Sciences or a related discipline
• Extensive experience within GMP-regulated pharmaceutical or biologics manufacturing environments
• Strong working knowledge of ICH Q9(R1) Quality Risk Management principles
• Proven experience leading and facilitating complex risk assessments across cross-functional teams
• Experience working with Quality Systems, Change Control, CAPA and GMP compliance programmes
• Strong understanding of digital manufacturing and system-enabled operations
• Experience supporting or governing 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 functions

Highly Desirable

• Previous experience establishing or managing site-wide QRM programmes
• Experience with PAS-X, Syncade, DeltaV, PI Historian, SAP or similar digital manufacturing platforms
• Data Integrity, Computer System Validation (CSV) or Computer Software Assurance (CSA) experience
• Experience supporting facility start-up, expansion or major transformation projects
• Operational resilience or business continuity experience within GMP environments
• Biologics or sterile manufacturing experience
• Previous regulatory inspection experience involving FDA, EMA or HPRA
• Lean Six Sigma or other continuous improvement qualifications

Experience

• 8+ years' experience in Quality Assurance, Quality Systems, Validation, Compliance or Quality Risk Management within the pharmaceutical or biotechnology sector
• Demonstrated experience leading risk-based quality initiatives in highly regulated GMP environments

#LI-BC1