QA Quality Risk Management Lead

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

Job summary

LSC is seeking a Quality Risk Management Lead for a 12‑month contract at a state‑of‑the‑art biopharma campus in Limerick, Ireland. The role requires extensive GMP/pharma/biologics QRM experience and strong knowledge of ICH Q9, with emphasis on risk assessment practices and a move to digital systems.

You will lead cross‑functional risk activities, influence site quality governance, and manage stakeholder meetings in a high‑caliber manufacturing environment.

Qualifications

• Extensive QRM experience in GMP-regulated pharma/biologics.
• Strong knowledge of ICH Q9 and digital manufacturing concepts.
• Ability to operate at a strategic level influencing quality governance.

Responsibilities

• Design and implement a facility-wide QRM framework aligned with ICH Q9(R1).
• Lead senior risk management activities across functions from risk questions to resolution.
• Discuss methodologies in detail during interviews and ensure robust risk handling.
• Prioritize risks by urgency and business impact; manage stakeholder meetings.
• Navigate cross-functional risk assessments and adapt approaches as needed.
• Utilize risk assessment tools and prepare transition to an electronic system.
• Maintain thorough knowledge of FMEA as the core risk assessment method.

Skills

Quality Risk Mgmt

Stakeholder mgmt

Risk assessment

ICH Q9 knowledge

Digital manufacturing

Tools

FMEA

Job description

Are you ready to be at the forefront of biotechnology excellence? LSC has 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, 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 works 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.

Find out more about working with LSC at lscconnect.com