Quality Risk Management Lead (12M, Life Sciences, Limerick)

QA QUALITY RISK MANAGEMENT LEAD, DIGITAL CORE IMPLEMENTATION required by CareerWise Recruitment for our Life Sciences client in Limerick. Initial 12 month contract on offer with site presence required 5 days per week on-site. This role sits within the Quality Assurance group.

Strong knowledge of ICH Q9, digital manufacturing concepts required. Experience addressing operational resiliency, data integrity, and business continuity in digital or paperless environments.

NOTE: No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.

Essential Duties and 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.

Education and Experience

• 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.

Please call Conor Twomey today for further information on 204 or email: