We are seeking a QA Compliance Specialist 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 inspection ready, 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.
Education:
Experience:
- Quality Compliance: 3 years (preferred)
- Quality Risk Management: 3 years (preferred)
- digital systems -DCS, MES, eBR, ERP, : 3 years (preferred)
- IT and automation systems: 3 years (preferred)
- system-enabled operations: 3 years (preferred)
- Manufacturing & digital systems operations: 3 years (preferred)
- ICH Q9 frameworks: 3 years (required)
Work authorisation:
Work Location: In person
