I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Thomas Gallagher
Life Science

+353870612325
[email protected]
Connect with me on
R&D Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Quality Specialist
Tipperary
R&D Director
Galway
Recruitment Consultant
Republic of Ireland
Trainer
Dublin
R&D Manager
Galway
Head of R&D
Galway
Project Manager
Limerick
Project Engineer
Tipperary
Senior Recruitment Consultant
Republic of Ireland
Process Engineer
Limerick
Analytical Chemist
Tipperary
Project Engineer
Republic of Ireland
R&D Manager
Galway
R&D Manager
Galway
Senior Quality Engineer-Remote
Republic of Ireland
Project Engineer
Limerick
Qualified Person
Limerick
Senior Recruitment Consultant
Republic of Ireland
C&Q Lead
Tipperary
R&D Director
Galway
Chemical Engineer
Tipperary
R&D Director
Galway
CQV Lead
Tipperary
Senior R&D Engineer
Galway City
R&D Manager
Galway
Medical Device Director
Republic of Ireland
Responsible Person (RP)
Republic of Ireland
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Quality Systems Manager


Reference:TG - QSM - Dublin Location: Dublin
Dublin City Centre
Dublin Greater
Dublin North
Dublin South
Dublin West
Kildare
Laois
Leinster
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Company:
My client are 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 - Senior
Location: Newenham Court, Northern Cross, Malahide rd, Dublin 17
Team: 6 direct reports
Hybrid working: 2-3 days a week on site per week
Benefits: Competitive salary, 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 Viatris Global policies.
    • Support general GDD activities as they arise


Does this sound like your next career move? For more info forward your application or contact me on 087 0612325 OR [email protected]