Digital QRM Leader for Next-Gen Biologics

PSC Biotech® Corporation; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

PSC Biotech® Corporation is seeking a QRM Lead to redefine and embed a risk-based quality management approach for a new, digitally enabled biologics facility. The role ensures that quality risk management is applied across processes, systems, and operations, with emphasis on operational resiliency and paperless manufacturing.

You will collaborate with Quality, Manufacturing, IT, Automation and Engineering to identify and mitigate risks, ensure inspection readiness, and drive governance at a

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 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 experience

ICH Q9

Digital manufacturing

Data integrity

Regulatory compliance

Strategic influence

Job description

PSC Biotech® Corporation is seeking a QRM Lead to redefine and embed a risk-based quality management approach for a new, digitally enabled biologics facility. The role ensures that quality risk management is applied across processes, systems, and operations, with emphasis on operational resiliency and paperless manufacturing.

You will collaborate with Quality, Manufacturing, IT, Automation and Engineering to identify and mitigate risks, ensure inspection readiness, and drive governance at a