QA – Quality Risk Management Lead

Innopharma Technical Services, part of Innopharma Group, specialises in the training and provision of highly skilled, project-ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector. We are seeking a QA with Strong Quality Risk Management expertise to provide support to our multinational pharmaceutical client site based in Munster province.

About the position:

The QRM Lead will help develop and implement a practical, risk-based approach to quality management for a new digitally enabled biologics manufacturing facility. The role will ensure that quality risks are identified, assessed, and managed consistently across processes, systems, and operations, with a strong focus on operational resilience, reliance on digital systems, and maintaining manufacturing operations in a paperless environment.

Key Responsibilities:

• Develop and implement a modern, site-wide Quality Risk Management (QRM) framework aligned with ICH Q9(R1) and designed to support a fully digital manufacturing facility.
• Integrate risk-based thinking into all areas of facility startup, including manufacturing processes, digital systems, automation, data management, and quality oversight.
• Identify, assess, and manage risks associated with reliance on digital and corporate systems, including DCS, MES, eBR, ERP, data historians, and network infrastructure.
• Establish and manage business continuity and contingency plans to maintain GMP compliance during system outages, such as network or cloud service disruptions, including controlled fallback processes for paperless manufacturing.
• Work closely with Quality, Manufacturing, IT, Automation, and Engineering teams to ensure risks are identified early, effectively mitigated, and clearly assigned to responsible owners.
• Ensure all risk assessments and decisions are science-based, well documented, and inspectionready, supporting regulatory confidence in a highly digital manufacturing environment.

Preferred Experience:

• Level 8 Degree in Science or related Discipline.
• 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.

Note:

• Due to the nature of the business, additional duties may be required from time to time.
• All applicants must be residing in Ireland, with Valid visa to work.

INNOPHARMA, RAVENSCOURT BUSINESS PARK, THREE ROCK RD, SANDYFORD, DUBLIN 18, D18 K599, IRELAND