Overview
A leading global life-science organisation is expanding its Dublin site, a centre focused on advanced manufacturing, quality operations, and the digital enablement of enterprise processes.
As part of this growth, the team is seeking a
Digital Quality Manager
to support the harmonisation and oversight of enterprise systems, ensuring they meet the highest standards of digital and regulatory compliance.
Responsibilities
Provide quality leadership for digital platforms, including enterprise systems, quality management tools, and site-level applications.
Drive harmonisation efforts across global and site-based teams to ensure aligned processes and digital standards.
Support CSV activities, ensuring compliance with GMP, data integrity expectations, Annex 1 requirements, and broader digital regulations.
Oversee quality processes related to deviations, CAPAs, change controls, and risk assessments with a strong understanding of regulatory expectations.
Contribute to the future evolution of the site QMS.
Support digital transformation initiatives aimed at streamlining processes, improving user experience, and enhancing compliance.
Partner with global colleagues across quality systems, lab workstreams, standards, metrics, and enterprise platforms to ensure coordinated implementation of digital quality strategy.
Provide quality oversight for artwork processes and support the evaluation and implementation of new artwork systems.
Offer guidance to cross-functional teams on system requirements, quality best practices, and digital design principles.
Act as a key member of the Quality Systems group, contributing to a growing portfolio of active projects and future secondment opportunities.
Build toward a strategic leadership remit, with potential for broader ownership of digital quality direction on site.
Experience
Minimum of 5 years of experience in a similar role within the pharmaceutical or biopharmaceutical industry.
Solid understanding of GMP, data integrity principles, and digital compliance requirements.
Comfortable collaborating across technical, operational, and quality teams.
Able to influence, challenge, and drive alignment in a complex, global environment.
Proactive mindset with strong problem-solving and communication skills.
Comprehensive and competitive total rewards package.
To learn more about this role apply online or contact Treasa Prior at HRM on + for a confidential discussion.
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