Quality Risk Lead - Digital Core Manufacturing

HERO Recruitment; Limerick; On-site; EUR 110,000 - 170,000; Full time

Job summary

HERO Recruitment seeks a Quality Risk Management Lead for a new, digitally enabled biologics manufacturing facility. The role redefines and embeds a risk-based quality management approach across processes, systems, and operations, with a focus on operational resiliency, digital system dependency, and paperless manufacturing continuity.

The candidate will design and govern a facility-wide QRM framework aligned with ICH Q9(R1) and drive risk-based thinking in startup activities, ensuring

Qualifications

• Extensive experience in Quality Risk Management within GMP-regulated pharma or biologics manufacturing.
• Strong knowledge of ICH Q9(R1), 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 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.

Skills

Quality risk management

GMP/regulatory

ICH Q9(R1)

digital manufacturing

system-enabled operations

operational resiliency

data integrity

business continuity

strategic influence

quality governance

Job description

HERO Recruitment seeks a Quality Risk Management Lead for a new, digitally enabled biologics manufacturing facility. The role redefines and embeds a risk-based quality management approach across processes, systems, and operations, with a focus on operational resiliency, digital system dependency, and paperless manufacturing continuity.

The candidate will design and govern a facility-wide QRM framework aligned with ICH Q9(R1) and drive risk-based thinking in startup activities, ensuring