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.
Benefits
* 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.