Our client is a multidisciplinary healthcare company with a strong and established presence in Ireland. Due to internal promotions and career progression the company is seeking to appoint a new Executive Director of Quality Operations. The Irish operations encompass high-value manufacturing units, R&D Financial Services, and global supply chain activities. The position will report to the Global VP of Operational Quality and also to the site Managing Director.
The company is seeking an individual with an outstanding track record in defining, designing and delivering QA services in a high-volume FDA regulated business. Key deliverables will include:
Candidates will have a primary degree level qualification in Science Engineering and will be certified to act as a Qualified Person (QP).
They will have a minimum of 15 years overall experience in industry with a minimum of 5 years in a similar role, ideally managing a Quality organisation of in excess of 100 staff. They will have the presence and breadth of knowledge to quickly and deeply understand the key technologies and business imperatives of the site.
They will have an in-depth and current knowledge of all relevant GxP and Quality System requirements (US, EU, ISO, MDD) for pharmaceutical and medical device development, manufacturing and related activities.
The will be experienced in leading and managing regulatory inspections with Global Competent Authorities and Notified Bodies and of interacting with and representing the company to Health Authorities, their agents, or related entities.
For further information on this role, please contact Conor Harty at Harty Search & Selection;