Quality Risk Management Lead

PE Global; Limerick; On-site; EUR 110,000 - 140,000; Full time

Job summary

PE Global is seeking a QA Risk Management Lead for a leading biotech company in Limerick on an initial 12-month contract. The role focuses on establishing a risk-based quality management program for a new digitally enabled biologics facility, ensuring quality risk management is applied across start-up, operations, and paperless manufacturing.

The candidate will embed risk-based decision-making, partner with Quality, Manufacturing, IT and Engineering, and ensure audit-ready risk decisions across

Qualifications

• Extensive QRM experience in GMP-regulated pharmaceutical or biologics manufacturing.
• Strong knowledge of ICH Q9(R1), digital manufacturing and system-enabled operations.
• Demonstrated ability to influence site design, operating models and quality governance.
• Experience managing operational resilience, data integrity and business continuity risks in digital or paperless environments.

Responsibilities

• Establish and manage the facility QRM program in accordance with applicable regulations, ICH Q9(R1) and internal procedures.
• Select appropriate risk assessment methods and facilitate the completion, periodic review and communication of risk assessments.
• Embed risk-based decision-making across facility start-up, manufacturing, automation, data flows and quality oversight.
• Ensure risk decisions are science-based, documented and inspection-ready.
• Partner with Quality, Manufacturing, IT, Automation and Engineering to identify, mitigate and assign ownership of risks.
• Develop and maintain the risk management plan for digital and corporate systems, including DCS, MES, eBR, ERP, data historians and network infrastructure.
• Support project quality and business objectives relating to GxP risk management.

Skills

QRM experience

ICH Q9(R1) knowledge

Digital manufacturing

Quality governance

Data integrity

Tools

DCS

MES

eBR

ERP

Data historians

Network infrastructure

Job description

The role:

PE Global is currently recruiting for a QA Risk Management Lead on behalf of a leading biotech company based in Limerick. This is an initial 12-month contract role.

Summary:

The QRM Lead will establish and embed a risk-based quality management program for a new digitally enabled biologics manufacturing facility. As the project QRM subject-matter expert, they will ensure that quality risk management is systematically applied across facility start-up, operational resilience, digital system dependency, and paperless manufacturing continuity.

Responsibilities:

• Establish and manage the facility QRM program in accordance with applicable regulations, ICH Q9(R1) and internal procedures.
• Select appropriate risk assessment methods and facilitate the completion, periodic review and communication of risk assessments.
• Embed risk-based decision-making across facility start-up, manufacturing, automation, data flows and quality oversight.
• Ensure risk decisions are science-based, documented and inspection-ready.
• Partner with Quality, Manufacturing, IT, Automation and Engineering to identify, mitigate and assign ownership of risks.
• Develop and maintain the risk management plan for digital and corporate systems, including DCS, MES, eBR, ERP, data historians and network infrastructure.
• Support project quality and business objectives relating to GxP risk management.

Education and Experience:

• Extensive QRM experience in GMP-regulated pharmaceutical or biologics manufacturing, including use of multiple risk assessment methods and facilitation of complex risk assessments.
• Strong knowledge of ICH Q9(R1), digital manufacturing and system-enabled operations.
• Demonstrated ability to influence site design, operating models and quality governance.
• Experience managing operational resilience, data integrity and business continuity risks in digital or paperless environments.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland