Our Client, Allergan, a leading Biopharmaceutical Manufacturer, is seeking an Executive Director Quality Operations for their flagship site based in the West of Ireland. The Executive Director will be the head of Quality for the manufacturing site, overseeing all aspects of product quality by leading and directing all the site quality organisation and functions.
Responsibilities include but are not limited to:
- Implementing and managing an effective Quality Management System to ensure continued compliance with all global regulatory requirements and Primary Qualified Person.
- Management Representative responsible party for the establishing and maintaining quality system activities on site or at another company entity as it relates to the manufacture, release, vigilance, incident reporting and batch recall of medical device products.
- Responsible for reporting the performance of the quality system in accordance with regulations. The Executive Director of Quality Operations is the key site contact for all product Quality related issues within and outside the organisation.
- BS/MS in Scientific Discipline. Must be qualified / recognised to hold Qualified Person status.
- 10+ years' experience in Pharma/Device industry. 5-7 years' leadership experience in Quality or Quality related function.
- Aseptic experience.
- 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.
- Experience of 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.
- Excellent analytical, communication, managerial and leadership skills.
- Practical working knowledge and experience in product development, design controls, and risk management principles and implementation.
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