Quality Manager

My client, a global pharmaceutical company now have an exciting new vacancy for a QA Manager.    

The successful candidate will support the further development and implementation of a global quality management system, obtain local HPRA Authorisations such as MIA and help further promote a culture of Quality within all functional operations.

Responsibilities
The primary responsibilities of this position include but are not limited to the following;
•    Support the establishment of a fit-for-purpose QMS system 
•    Management of the components of the QMS, which consists of, but not limited to: change control, deviations, CAPAs, procedures, training, complaints, documentation, audits, inspections and vendor management.
•    Application for a Manufacturers and Import Authorisation (MIA)
•    Potential to help establish the process for Batch Release /QP Release activities from Dublin office
•    Support Global Pharmacovigilance, Regulatory Affairs, Clinical Development, Supply Chain, CMC Regulatory Affairs’ teams to ensure that QMS is compliant with applicable Global and EU regulatory requirements.
•    Be a key lead member during regulatory inspections and internal and external audits.
•    Compile and manage Quality metrics and KPIs.
•    Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
•    Ability to establish working relationships with people globally, in various functions with a wide variety of disciplines and backgrounds. 

Qualifications/Experience:

•    Degree in Life Sciences.
•    Minimum 6 years’ experience in Quality environment in Pharma
•    Track record of QMS, SOP creation and audit/inspections.
•    Understands and maintains strong working knowledge of GxP, global regulations and guidelines for pharmaceutical companies.
•    Qualified QP Status is an advantage
•    Although primarily focusing on Medicinal Products, experience with Medical Devices is an advantage.

For full details and confidential discussion please email tdunne@thornshaw.com or call  Tina @ +1 2784671
www.thornshaw.com

#Quality Assurance