QA Risk Management Lead

PE Global; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

PE Global is recruiting for a QA Risk Management Lead in Limerick on a 12-month contract basis. The role focuses on establishing a risk-based quality management program for a new digitally enabled biologics manufacturing facility and ensuring QRM is applied across start-up, operations, and digital systems.

The successful candidate will bring extensive QRM experience in GMP-regulated environments, strong knowledge of ICH Q9(R1), and the ability to influence quality governance and site design.

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

Education

GMP/Biologics industry experience

Job description

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***