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Confidential
QA Quality Risk Management LeadConfidential • Limerick, Wexford, Ireland
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Confidential

QA Quality Risk Management Lead

Confidential
  • IE
    Limerick, Wexford, Ireland
  • IE
    Limerick, Wexford, Ireland
Postuler Maintenant

À propos

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.
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.
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.
Embed risk-based thinking into all aspects of facility startup, including manufacturing processes, digital systems, automation, data flows, and quality oversight.
Assess and manage risks related to dependency on digital and corporate systems, including DCS, MES, eBR, ERP, data historians, and network infrastructure.
Define and govern business continuity and contingency strategies to ensure GMP compliance during system outages (e.g., network failures, cloud unavailability), including controlled fallback for paperless operations.
Partner with Quality, Manufacturing, IT, Automation, and Engineering to ensure risks are proactively identified, mitigated, and owned.
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. xyswxtq
Apply via this advert or contact Siobhan Cummins on if you have any questions about this role.
Find out more about working with LSC at Skills: quality assurance quality risk management digital system
TPBN1_IJ
  • Limerick, Wexford, Ireland

Compétences linguistiques

  • English
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