Quality Risk Lead – Digital Core (Biologics, On-site)

QPTech Ltd; Limerick; On-site; EUR 110,000 - 138,000; Full time

Job summary

QPTech Ltd. is seeking a senior Quality Risk Management Lead to support a major Digital Core implementation for a biologics manufacturing facility in Limerick.

The role requires embedding risk-based thinking across Quality, Manufacturing, IT, Automation and Engineering to ensure GMP compliance and inspection readiness. The successful consultant will design and embed a modern risk management framework aligned with ICH Q9, lead cross-functional workshops and influence the Quality operating model

Qualifications

• Extensive Quality Risk Management experience within a GMP-regulated pharmaceutical/biologics environment.
• Strong working knowledge of ICH Q9 (R1).
• Experience designing or improving risk management frameworks.
• Experience with digital manufacturing and system-enabled operations.
• Experience with MES, eBR, ERP, DCS, data historians.
• Strong stakeholder management and cross-functional leadership.
• Excellent documentation and communication skills.

Responsibilities

• Design and implement a modern, facility-wide Quality Risk Management framework, aligned with ICH Q9(R1).
• Embed risk-based thinking throughout facility start-up activities, including manufacturing processes, digital systems, automation, data flows and Quality oversight.
• Lead the identification, assessment, mitigation and ongoing management of Quality and operational risks.
• Assess risks associated with the facility's dependency on digital and corporate systems, including DCS, MES, eBR, data historians and IT infrastructure.
• Define and govern business continuity and contingency strategies that maintain GMP compliance during digital system outages.
• Establish controlled fallback arrangements for paperless manufacturing operations in failure scenarios.
• Partner with Quality, Manufacturing, IT, Automation and Engineering to ensure risks are mitigated and owned.
• Facilitate cross-functional Quality Risk Management workshops and provide strategic guidance to senior stakeholders.
• Ensure risk assessments and Quality decisions are scientifically justified and inspection-ready.
• Support regulatory confidence in the facility’s highly digital operating model.
• Promote consistent application of Quality Risk Management principles across the site.

Skills

Quality Risk Management

GMP experience

Stakeholder management

Cross-functional leadership

Digital manufacturing

Tools

MES

eBR

ERP

DCS

Data historians

Job description

QPTech Ltd. is seeking a senior Quality Risk Management Lead to support a major Digital Core implementation for a biologics manufacturing facility in Limerick.

The role requires embedding risk-based thinking across Quality, Manufacturing, IT, Automation and Engineering to ensure GMP compliance and inspection readiness. The successful consultant will design and embed a modern risk management framework aligned with ICH Q9, lead cross-functional workshops and influence the Quality operating model