Digital Biologics QRM Lead

PSC Biotech Corporation; Limerick; On-site; EUR 90,000 - 135,000; Full time

Job summary

PSC Biotech is seeking a QRM lead in Limerick to redefine a risk-based quality management approach for a digitized biologics facility. You will drive systemic risk controls across processes, systems, and operations while focusing on operational resiliency and paperless manufacturing.

Ideal candidates have extensive GMP experience, strong knowledge of ICH Q9, and the ability to influence site design and governance.

Qualifications

• Extensive experience in Quality Risk Management within GMP pharma or biologics.
• Strong knowledge of ICH Q9 and digital manufacturing concepts.
• Ability to influence site design, operating models and governance.
• Experience with data integrity and business continuity in digital environments.

Responsibilities

• Design and implement a modern QRM framework for a digital plant.
• Embed risk-based thinking across startup, processes, and systems.
• Assess risks from digital systems, DCS, MES, ERP and network.
• Define governance for continuity during system outages.
• Collaborate with Quality, Manufacturing, IT, Automation to mitigate risks.
• Ensure decisions are documented and inspection-ready for regulatory confidence.

Skills

Quality Risk Management

GMP Compliance

Digital Manufacturing

Strategic Influence

Education

Extensive GMP/pharma industry experience

Job description

PSC Biotech is seeking a QRM lead in Limerick to redefine a risk-based quality management approach for a digitized biologics facility. You will drive systemic risk controls across processes, systems, and operations while focusing on operational resiliency and paperless manufacturing.

Ideal candidates have extensive GMP experience, strong knowledge of ICH Q9, and the ability to influence site design and governance.