I want to reach out about an exclusive new role I am recruiting for in Malahide, Dublin 17.


Company:
My client are a Pharma and Medical Device company developing combination products whoare have a global portfolio which includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.
They are committed to helping create healthier communities worldwide through education, outreach and better access to treatment


Role: Quality Systems Manager
Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17
Team: 8 direct reports
Hybrid working: 2-3 days a week on site per week
Benefits: Competitive salary, 10-15% bonus, pension and full family healthcare

Day to day:
Manage and maintain the Quality Management System for GDD - ensuring compliance is maintained against ISO 13485: 2016, 21 CFR 820 (and relevant territorial Quality System requirements as they arise within the organization);

• Monitor the performance of the QMS and implement necessary remediation activities to ensure steady state performance
• Support the management representative, by conducting and reporting on the performance of the GDD QMS at Management Review.
• Leads implementation and continuous improvement of the GDD Quality Manual, Quality Policy, CAPA process, Complaints process, Change Control process, Internal audit process, training process.
• Leads the implementation of Global Quality Policy introduction / updates to the GDD QMS, while providing necessary
• Establish and manage the GDD internal audit schedule, while participating in and supporting the execution of Internal audits as necessary
• Manage the preparation for, and front external audits of GDD; for example Global Corporate Auditing, Certification / Notified Body audits, Health Authority inspections.
• Establish, plan and implement activities within the post-production phase for:
  • Integrating combination products & medical devices into GDD portfolio
  • Post-production phase programs that have transferred to relevant Viatris Affiliate for commercialisation
  • Maintain awareness of ongoing industry best practices, new QSRs and QMSs requirements as they are developed, and implement improvement actions for the GDD QMS, including additional regional requirements to support program delivery
  • Establish and rollout best practice training to GDD personnel and relevant Affiliate sites, to ensure compliance with GDD requirements and Global policies.
  • Support general GDD activities as they arise