Digital Quality Risk Lead — Onsite in Limerick

PE Global (UK); Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

PE Global are recruiting a QA Quality Risk Management Lead to redefine and embed a risk-based QRM approach for a new digitally enabled biologics manufacturing facility in Limerick. The role focuses on operational resiliency, digital system dependency, and paperless manufacturing continuity.

The candidate will partner with Quality, Manufacturing, IT, Automation and Engineering to ensure risks are identified, mitigated, and owned; decisions must be science-based and inspection-ready to support

Qualifications

• Extensive experience in Quality Risk Management within GMP-regulated pharma or biologics manufacturing.
• Strong knowledge of ICH Q9, digital manufacturing concepts, and system-enabled operations.
• Proven ability to operate at a strategic level, influencing site design, operating models, and quality governance.
• Experience addressing operational resiliency, data integrity, and business continuity in digital or paperless environments.

Responsibilities

• Design and implement a modern, facility-wide Quality Risk Management (QRM) framework, aligned with ICH Q9(R1), supporting a fully digital plant.
• Embed risk-based thinking into all aspects of facility startup, including manufacturing processes, digital systems, automation, data flows, and quality oversight.
• Assess and manage risks related to dependency on digital and corporate systems, including DCS, MES, eBR, ERP, data historians, and network infrastructure.
• Define and govern business continuity and contingency strategies to ensure GMP compliance during system outages (e.g., network failures, cloud unavailability), including controlled fallback for paperless operations.
• Partner with Quality, Manufacturing, IT, Automation, and Engineering to ensure risks are proactively identified, mitigated, and owned.
• Ensure risk decisions are science-based, documented, and inspection-ready, supporting regulatory confidence in a highly digital operating model.

Skills

Quality Risk Management

ICH Q9 knowledge

Digital manufacturing concepts

Regulatory compliance mindset

Strategic influence

Job description

PE Global are recruiting a QA Quality Risk Management Lead to redefine and embed a risk-based QRM approach for a new digitally enabled biologics manufacturing facility in Limerick. The role focuses on operational resiliency, digital system dependency, and paperless manufacturing continuity.

The candidate will partner with Quality, Manufacturing, IT, Automation and Engineering to ensure risks are identified, mitigated, and owned; decisions must be science-based and inspection-ready to support