Responsible for providing expertise and leadership in the Quality function. Responsible to ensure that licensed product is certified and released to market in compliance with commercial manufacturing license and clinical (IMP) products in accordance with EU directive 2001/83/EC, 2004/94/EC and in accordance with the requirements.
Essential Duties and Responsibilities
1. Owns and continuously improves the batch disposition of Quality in the Industrial Operations and Product Supply organization.
2. Responsible for disposition of medicinal product in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.
3. Interacts with critical biotechnology commercial and clinical API and Fill/Finish manufacturing operations, facilities and Quality Control laboratories to ensure a successful compliance profile.
4. Partners with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfaces with customer/partner quality organisations, and negotiates third party contractor and supplier quality agreements.
5. May organise QA resource assigned to functional area to meet goals and timings; coordinates prioritisation of activities with area management.
6. Participates in cross functional teams as Quality/Qualified Person representative as required.
7. Provides advice and direction to other company departments on quality and regulatory issues.
8. Acts as an auditor on behalf of Regeneron Ireland.
9. Involved in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensures regulatory observations are adequately addressed and completed on schedule.
10. Authorises significant deviations to established, approved procedures, provides guidance to assist co-workers with troubleshooting investigations and problem resolution.
11. Ensures safety and operational standards are maintained.
Education and Experience:
1. Third level qualification (degree in science or related discipline preferred) appropriate for QP eligibility.
2. A minimum of 10 years of related experience in the pharmaceutical/biotechnology industry with at least 5 years relevant work experience acting as Qualified Person, named on the Manufacturing and Importation Authorisation (MIA) license.
#J-18808-Ljbffr