Quality Risk Management Lead

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

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