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Posted 15 hours agoQuality Risk Management (QRM) Lead
Limerick, IrelandOn-site
Responsibilities
- Embed risk-based thinking into facility startup, covering manufacturing processes, automation, data flows, and quality oversight.
- Define contingency strategies to maintain GMP compliance and operational continuity during digital system or network outages.
- Collaborate with Quality, Manufacturing, IT, and Engineering to ensure risks are proactively identified and owned.
- Ensure all risk-based decisions are science-backed, documented, and fully ready for regulatory inspections.
- Design & implement a modern, facility-wide QRM framework aligned with ICH Q9(R1) to support a fully digital plant.
Requirements
- Requirements: Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical discipline.
- Extensive background in Quality Risk Management within a GMP-regulated biologics or pharmaceutical manufacturing environment.
- Deep knowledge of ICH Q9, digital manufacturing concepts, and system-enabled operations. Proven
- experience handling business continuity, data integrity, and fallback strategies in paperless environments.
Additional details
- We are seeking a Quality Risk Management (QRM) Lead who will design, implement, and govern a risk-based quality management framework for a state-of-the-art, digitally enabled biologics manufacturing facility.
- This role focuses on embedding systematic risk management across automated processes, ensuring operational resiliency, and establishing business continuity strategies for paperless operations.
- Assess and mitigate risks tied to digital systems and network infrastructure (e.g., MES, eBR, DCS, ERP).