QRM Lead

QRM Lead – Limerick, Ireland – Initial 12-Month Contract – Life Sciences

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 assignment has arisen to support a global pharmaceutical organisation on a major expansion project based in the picturesque Limerick, on an initial 12 month contract. 

What you’ll deliver:

• Establish and manage the site Quality Risk Management (QRM) programme in line with ICH Q9(R1) and GMP requirements.
• Lead and facilitate complex risk assessments, ensuring appropriate methodologies are selected and risks are effectively communicated and managed.
• Embed risk-based decision making across manufacturing, quality, engineering, automation, and digital systems within a new biologics facility.
• Partner with cross-functional teams to identify, assess, mitigate, and monitor quality risks while ensuring decisions are documented and inspection-ready.

Experience required:

• Extensive Quality Risk Management experience within GMP-regulated pharmaceutical, biotech, or biologics manufacturing environments.
• Strong working knowledge of ICH Q9(R1) and experience applying risk management principles in regulated settings.
• Proven experience facilitating complex risk assessments and leading site-wide QRM programmes.
• Experience working with digital manufacturing systems and managing operational, quality, and data integrity risks across business-critical processes.

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

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