Quality Risk Lead: Pharma/Biotech QRM Expert (Contract)

Life Science Consultants; Limerick; On-site; EUR 90,000 - 120,000; Full time

Job summary

Life Science Consultants in Ireland is seeking a Quality Risk Management Lead for a 12-month contract at a state-of-the-art Limerick biopharma campus. You will design and implement a GMP-compliant QRM framework aligned with ICH Q9(R1), lead cross-functional risk activities, and adapt risk approaches as needed during a transition to an electronic system.

The ideal candidate has extensive GMP/pharma/biotech risk experience, strong knowledge of ICH Q9, digital manufacturing concepts, and proven

Qualifications

• Extensive experience in Quality Risk Management within GMP-regulated pharma or biotech.
• Strong knowledge of ICH Q9 and digital manufacturing concepts.
• Ability to influence site design, operating models and quality governance.

Responsibilities

• Design and implement a modern, facility-wide QRM framework aligned with ICH Q9(R1).
• Lead cross-functional risk management activities from initial assessment to completion.
• Manage stakeholders, meetings and prioritise risk based on urgency and impact.

Skills

Quality Risk Management

ICH Q9 knowledge

Stakeholder management

FMEA

Digital manufacturing concepts

Tools

FMEA

Risk assessment tools

Job description

Life Science Consultants in Ireland is seeking a Quality Risk Management Lead for a 12-month contract at a state-of-the-art Limerick biopharma campus. You will design and implement a GMP-compliant QRM framework aligned with ICH Q9(R1), lead cross-functional risk activities, and adapt risk approaches as needed during a transition to an electronic system.

The ideal candidate has extensive GMP/pharma/biotech risk experience, strong knowledge of ICH Q9, digital manufacturing concepts, and proven