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EXECUTIVE DIRECTOR OF QUALITY

EXECUTIVE DIRECTOR OF QUALITY

Company Background

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:

  • Contribute to site strategy development as a member of the site leadership team.
  • Identify and develop the required competencies for management staff at several levels to implement and sustain operational excellence programmes.
  • Oversee all aspects of product quality.
  • Lead and direct all the entire site quality organisation and function.
  • Be responsible for managing an effective Quality Management System to ensure continued compliance with all global regulatory requirements.
  • Be the Primary Qualified Person (QP) responsible for product release.
  • Act as the Management Representative Responsible Party for the establishing and maintaining quality systems and activities on site or at another corporate as it relates to the manufacture, release, vigilance, incident reporting and batch recall of products for which the corporation manufactures or acts as legal manufacturer.
  • Report on the performance of Site and Business Unit quality systems in accordance with regulations.

 

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;

Office:  +353-61-414533