QRM Lead

QRM Lead - Ireland, Limerick - 12 Months Initial Contract 

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the World. An exciting opportunity has arisen to work for a global pharmaceutical organisation on a major expansion project based in the picturesque Limerick. 

What you'll do:

• 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 across all aspects of facility startup, including manufacturing, digital systems, automation, data flows, and quality oversight.
• Assess and manage risks tied to critical digital and corporate systems (e.g., DCS, MES, eBR, ERP, data historians, network infrastructure).
• Define and govern business continuity and contingency strategies to ensure GMP compliance during system outages, including controlled fallback for paperless operations.

What you'll need:

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

If this role is of interest to you, please apply now!

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