Quality Risk Manager

QPTech Ltd; Limerick; On-site; EUR 110,000 - 138,000; Full time

Job summary

QPTech Ltd. is seeking a senior Quality Risk Management Lead to support a major Digital Core implementation for a biologics manufacturing facility in Limerick.

The role requires embedding risk-based thinking across Quality, Manufacturing, IT, Automation and Engineering to ensure GMP compliance and inspection readiness. The successful consultant will design and embed a modern risk management framework aligned with ICH Q9, lead cross-functional workshops and influence the Quality operating model

Qualifications

• Extensive Quality Risk Management experience within a GMP-regulated pharmaceutical/biologics environment.
• Strong working knowledge of ICH Q9 (R1).
• Experience designing or improving risk management frameworks.
• Experience with digital manufacturing and system-enabled operations.
• Experience with MES, eBR, ERP, DCS, data historians.
• Strong stakeholder management and cross-functional leadership.
• Excellent documentation and communication skills.

Responsibilities

• Design and implement a modern, facility-wide Quality Risk Management framework, aligned with ICH Q9(R1).
• Embed risk-based thinking throughout facility start-up activities, including manufacturing processes, digital systems, automation, data flows and Quality oversight.
• Lead the identification, assessment, mitigation and ongoing management of Quality and operational risks.
• Assess risks associated with the facility's dependency on digital and corporate systems, including DCS, MES, eBR, data historians and IT infrastructure.
• Define and govern business continuity and contingency strategies that maintain GMP compliance during digital system outages.
• Establish controlled fallback arrangements for paperless manufacturing operations in failure scenarios.
• Partner with Quality, Manufacturing, IT, Automation and Engineering to ensure risks are mitigated and owned.
• Facilitate cross-functional Quality Risk Management workshops and provide strategic guidance to senior stakeholders.
• Ensure risk assessments and Quality decisions are scientifically justified and inspection-ready.
• Support regulatory confidence in the facility’s highly digital operating model.
• Promote consistent application of Quality Risk Management principles across the site.

Skills

Quality Risk Management

GMP experience

Stakeholder management

Cross-functional leadership

Digital manufacturing

Tools

MES

eBR

ERP

DCS

Data historians

Job description

Quality Risk Management Lead Digital Core Implementation - Biologics Manufacturing

Contract Duration: 12-month rolling contract

Consultant Rate: €80-100 per hour, depending on experience

Engagement: Full-time contract consultancy position

The Opportunity

QPTech is seeking an experienced Quality Risk Management Lead to support a major Digital Core implementation within our client's new, digitally enabled biologics manufacturing facility in Limerick.

This is a senior strategic consulting opportunity for an experienced Quality professional who can help define, implement and embed a modern, risk-based Quality Management approach across a highly automated and predominantly paperless manufacturing environment.

The successful consultant will work across Quality, Manufacturing, IT, Automation and Engineering to ensure that Quality Risk Management is systematically applied throughout facility start-up, digital system implementation and ongoing operational readiness.

The position offers the opportunity to influence the Quality operating model of a major new manufacturing facility and play a central role in ensuring its digital systems, processes and contingency arrangements are robust, compliant and inspection-ready.

Key Responsibilities

• Design and implement a modern, facility-wide Quality Risk Management framework, aligned with ICH Q9(R1).
• Embed risk-based thinking throughout facility start-up activities, including manufacturing processes, digital systems, automation, data flows and Quality oversight.
• Lead the identification, assessment, mitigation and ongoing management of Quality and operational risks.
• Assess risks associated with the facility's dependency on digital and corporate systems, including:
• Distributed Control Systems (DCS)
• Manufacturing Execution Systems (MES)
• Electronic Batch Records (eBR)
• Data historians
• Network and supporting IT infrastructure
• Define and govern business continuity and contingency strategies that maintain GMP compliance during digital system outages.
• Establish controlled fallback arrangements for paperless manufacturing operations in scenarios such as network failure, cloud service disruption or system unavailability.
• Partner with Quality, Manufacturing, IT, Automation and Engineering teams to ensure that risks are proactively identified, appropriately mitigated and assigned to accountable owners.
• Facilitate cross-functional Quality Risk Management workshops and provide strategic guidance to senior stakeholders.
• Ensure risk assessments and Quality decisions are scientifically justified, clearly documented and inspection-ready.
• Support regulatory confidence in the facility’s highly digital operating model.
• Promote consistent and effective application of Quality Risk Management principles across the site.

The ideal consultant will have:

• Extensive Quality Risk Management experience within a GMP-regulated pharmaceutical, biotechnology or biologics manufacturing environment.
• Strong working knowledge of ICH Q9 and ICH Q9(R1).
• Experience designing, implementing or improving Quality Risk Management frameworks at site or enterprise level.
• Strong understanding of digital manufacturing and system-enabled pharmaceutical operations.
• Experience working with manufacturing and Quality systems such as MES, eBR, ERP, DCS, data historians or related digital platforms.
• Demonstrable experience addressing:
• Operational resilience
• Data integrity
• Business continuity
• Paperless manufacturing risks
• The ability to operate at a strategic level and influence facility design, operating models and Quality governance.
• Strong stakeholder management and cross-functional leadership skills.
• The confidence to work effectively with senior representatives from Quality, Manufacturing, Engineering, Automation and IT.
• A structured, pragmatic and science-based approach to Quality decision-making.
• Excellent documentation, facilitation and communication skills.

Why Consider This Contract?

This is an opportunity to:

• Join a high-profile biologics manufacturing programme at a critical stage of facility development.
• Help shape the Quality Risk Management strategy for a modern, digitally enabled manufacturing site.
• Work at the intersection of Quality, manufacturing technology, automation and digital transformation.
• Influence important decisions relating to operational resilience, business continuity and regulatory readiness.
• Secure a long-term consultancy engagement through a 12-month rolling contract.
• Receive a competitive consultant rate of €80-100 per hour, depending on experience.

Position

Quality Risk Management Lead - Digital Core Implementation

Client

Pharmaceuticals

Working Arrangement

On-site

Duration

12-month rolling contract

Rate

€80-100 per hour, depending on experience

Sector

Biologics / Pharmaceutical Manufacturing

Department

Quality Assurance