Quality Risk Management 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

Limerick, Ireland | Posted on 10/07/2026

• Industry Pharma/Biotech/Clinical Research
• City Limerick
• State/Province Limerick
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Summary:

The QRM lead is responsible for redefining and embeddinga risk-based quality management approach for a new, digitally enabled biologicsmanufacturing facility. The role ensures that quality risk management issystematically applied across processes, systems, and operations, withparticular focus on operational resiliency, digital system dependency, andpaperless manufacturing continuity.

Requirements

Essential Duties and Responsibilities include, but arenot limited to, the following:

• Design and implement a modern, facility-wide Quality RiskManagement (QRM) framework, aligned with ICH Q9(R1), supporting a fully digitalplant.
  
• Embed risk-based thinking into all aspects of facilitystartup, including manufacturing processes, digital systems, automation, dataflows, and quality oversight.
  
• Assess and manage risks related to dependency on digitaland corporate systems, including DCS, MES, eBR, ERP, data historians, andnetwork infrastructure.
  
• Define and govern business continuity and contingencystrategies to ensure GMP compliance during system outages (e.g., networkfailures, cloud unavailability), including controlled fallback for paperlessoperations.
  
• Partner with Quality, Manufacturing, IT, Automation, andEngineering to ensure risks are proactively identified, mitigated, and owned.
  
• Ensure risk decisions are science-based, documented, andinspection-ready, supporting regulatory confidence in a highly digitaloperating model.
  

Education and experience:

• Extensive experience in Quality Risk Management withinGMP-regulated pharma or biologics manufacturing.
  
• Strong knowledge of ICH Q9, digital manufacturingconcepts, and system-enabled operations.
  
• Proven ability to operate at a strategic level,influencing site design, operating models, and quality governance.
  
• Experience addressing operational resiliency, dataintegrity, and business continuity in digital or paperless environments.