QRM Lead– Digital Core implementation

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