Quality Risk Management Lead

Cpl • Biotechnology • 12-month contract • Bachelor's Degree • 6 days ago

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Location

Hybrid (Limerick, Ireland)

Seniority

Staff · 8+ years exp

Employment

Contractor

Confirmed on the employer's own hiring board on Oct 20, 2026. First seen by Alion on Oct 14, 2026. Cpl scores B on the Alion truth index.

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Cpl

Cpl is an Irish recruitment and workforce solutions company headquartered in Dublin, providing permanent, temporary, contract and executive recruitment, managed services such as RPO, and project and consulting solutions. Founded in Dublin in 1989 and owned by Brexa since 2024, it makes about 8,000 placements a year for more than 5,000 organisations across Ireland and the UK, and its group includes specialist brands such as Allen Lane and Kenny Whelan. Its job board carries vacancies for client employers, from accountants, customer service agents and AML specialists to engineers, software developers, production managers and drivers, mainly in Dublin, Galway, Limerick and Cork.

cpl.com • HQ: Dublin, Ireland • Executive Search • Recruiting & Staffing • Est. 1989

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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