QRM Lead — Digital GMP Quality Risk Architect

eConsulting; Limerick; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Private health insurance

Free English lessons

Access to training library

Sports activities

Team-building events

Job summary

eConsulting in Limerick is looking for a Quality Risk Management specialist to design and implement a digital plant framework. Your role will involve assessing risks and ensuring compliance in a highly digital environment.

We're seeking someone with at least 5 years of experience in GMP-regulated pharma, along with a strong knowledge of ICH Q9 and digital operations. The position offers an attractive benefits package and opportunities for professional development.

Qualifications

• 5+ years in Quality Risk Management in GMP-regulated pharma or biologics.
• Strong knowledge of ICH Q9 and digital manufacturing concepts.
• Experience with data integrity and business continuity in digital environments.

Responsibilities

• Design and implement a facility-wide Quality Risk Management framework.
• Embed risk-based thinking into facility startup processes.
• Assess and manage risks related to digital systems and corporate dependencies.
• Define business continuity strategies for GMP compliance.
• Partner with departments to ensure proactive risk identification.

Skills

Quality Risk Management

GMP-regulated pharma experience

Strategic influence

Operational resiliency

Data integrity

Business continuity

Job description

• 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.
  
  

Workplace: on-site (Limerick)

Workload: Full-time

Type of Contract: B2B

Key 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.
  
  

Required Skills And Experience

• At least 5 years of 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.
  
  

What do we offer?

• Benefits package (private health insurance, sports card, group insurance).
• Free English lessons with a dedicated teacher.
• Access to an extensive training library covering both soft and technical skills.
• Sports activities.
• Team-building events, contests, and challenges.
  
  

Who We Are – In a Nutshell

Industry: We operate in the IT sector.

Clients: We support international companies in regulated industries (banking, finance, insurance, pharmaceuticals).

Services: We provide comprehensive quality control and implement modern HR platforms for employee management.

How do we work? See what our employees say👉 Piotr i Julia