QA Lead, Quality Risk Management (12M, Limerick)

CareerWise Recruitment; Limerick; On-site; EUR 90,000 - 130,000; Full time

Job summary

CareerWise Recruitment is seeking a QA Quality Risk Management Lead for a Life Sciences client in Limerick. This is a 12-month contract with on-site presence five days per week, within the Quality Assurance group, to implement a digital QRM framework across the facility.

The successful candidate will bring extensive GMP QRM experience, strong ICH Q9 knowledge, and expertise in digital manufacturing, data integrity, and business continuity.

Qualifications

• 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.

Responsibilities

• Design and implement a modern, facility-wide 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, 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.

Skills

Quality Risk Management

ICH Q9

Digital Manufacturing

Regulatory Compliance

Education

Bachelor's degree in Life Sciences

Tools

DCS

MES

ERP

eBR

Job description

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 include, but are not limited to, the following:

• 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.

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.