QA Quality Risk Management Lead

Life Science Consultants; Limerick; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Quality Risk Management

ICH Q9 knowledge

Stakeholder management

FMEA

Digital manufacturing concepts

Tools

FMEA

Risk assessment tools

Jobbeschreibung

Job Description

Are you ready to be at the forefront of biotechnology excellence? LSC have a fantastic contract opportunity for a Quality Risk Management Lead to join an innovative and rapidly growing biopharmaceutical company at their state-of-the-art campus in Limerick. This company is transforming lives through groundbreaking medicines that treat serious diseases-from atopic dermatitis to high cholesterol and age-related blindness. If you have 5 years of experience working in the pharmaceutical or biotechnology industry and are ready to take the next step in your career, if this sounds like your next move, we'd love to hear from you. Contract | Limerick | Duration: 12 months

ABOUT THE PROJECT - KEY RESPONSIBILITIES:

• Design and implement a modern, facility-wide Quality Risk Management (QRM) framework, aligned with ICH Q9(R1), supporting a fully digital plant. Senior Risk Management role requiring a strong background in Pharma, Biotech or Medical Devices. Must have extensive experience in Risk Assessment Management and a thorough understanding of ICH Q9, with the ability to discuss methodologies in detail during interview. Proven experience leading cross-functional risk management activities from initial risk question through to completion, knowing when to reassess and adapt the approach. Strong stakeholder management skills, able to lead meetings, manage different personalities, prioritize risk based on urgency and business impact, and remain calm and highly organised under pressure. Experience using risk assessment tools is essential. The company is transitioning to an electronic system, so while this role won't lead the implementation, they will need to confidently use the new platform. Fully familiar with FMEA (Failure Mode and Effects Analysis) - the most common risk assessment methodology used under ICH Q9

ABOUT YOU - ARE YOUR SKILLS A MATCH?

Extensive experience in Quality Risk Management within GMP-regulated pharma or biologics manufacturing. Strong knowledge of ICH Q9, digital manufacturing concepts, and system-enabled operations. Proven ability to operate at a strategic level, influencing site design, operating models, and quality governance.

WHY LSC?

LSC work exclusively in the Life Sciences sector. Founded and run by contractors, we understand contracting first-hand and have created a unique approach to make the process as smooth as possible, so you can focus on delivering your best work. With over 23 years' experience supporting the industry, we bring deep sector knowledge and long-standing client relationships. At LSC, we partner with you for the long term, not just the duration of your contract. We are committed to building lasting relationships and will work closely with you to ensure you are placed on projects that challenge, develop, and reward you throughout your career.

What You Can Expect.

• Work on-site with leading biopharma organisations on high-impact projects
• Structured onboarding to ensure you're set up from day one
• Ongoing support and regular engagement from LSC throughout your assignment
• Be part of a wider LSC consultant network
• A dedicated team behind you; you're not navigating projects or contracts alone

Note: Are you currently eligible to work in Ireland? As this is a contract opportunity, you will need to hold a Stamp 1G or Stamp 4 visa to apply.