This organisation is a leading US Pharmaceutical company with offices and manufacturing sites across the US and Ireland. They are focused on developing and delivering pharmaceutical drugs across a number of core therapeutic areas. Due to the current Senior QA Manager taking an internal opportunity within the business, my client require an experienced Quality professional to join their team in Dublin on a permanent basis with flexibility to work from home.
Reporting into the Head Quality, as Senior Quality Manager will have responsibility for executing the QMS, overseeing a portfolio of CMO's, preparing and reviewing RA submissions including product annual reports, providing oversight to PV activities working with my clients service provider and overseeing artwork and labelling changes and executing QMS elements.
In order to be considered you must have the following:
A BSc / MSc in Science or related
8+ years' industry experience with a strong understanding of GMP
Previous experience with US FDA and associated regulatory requirements
External Quality experience - CMO Management or supplier management
Pharmaceutical experience - Solid dose or topical experience - desirable
Previous experience with electronic document management systems (Trackwise etc.)
To discover more about this opportunity, apply now or contact Gillian McMurrough at HRM on +353 87 1213548 for a confidential discussion.