Senior Quality Risk Manager – Digital GMP Core

Cpl; Limerick; Hybrid; EUR 110,000 - 140,000; Full time

Job summary

CPL is seeking an experienced Quality Risk Management Lead to guide the implementation of a digitally enabled manufacturing environment for a leading biopharma facility. The role requires embedding QRM across Quality, Manufacturing, Automation and IT, with collaboration across cross-functional teams to identify and mitigate risks.

You will lead the QRM programme, drive risk-based decision making and ensure regulatory and inspection readiness while supporting complex risk assessments and change

Qualifications

• Degree in Science, Engineering, Quality, Pharmaceutical Sciences or related discipline.
• 8+ years in QA, QMS, validation, compliance or QRM in pharma/biotech.
• Experience leading risk-based quality initiatives in GMP environments.
• Strong knowledge of ICH Q9(R1) QRM principles.

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.

Skills

Stakeholder management

Communication

Quality Risk Management principles

Leadership

Education

Degree in Science, Engineering or Quality

Tools

MES

eBR

DCS

ERP

CSV

Job description

CPL is seeking an experienced Quality Risk Management Lead to guide the implementation of a digitally enabled manufacturing environment for a leading biopharma facility. The role requires embedding QRM across Quality, Manufacturing, Automation and IT, with collaboration across cross-functional teams to identify and mitigate risks.

You will lead the QRM programme, drive risk-based decision making and ensure regulatory and inspection readiness while supporting complex risk assessments and change