Associate Director Qualified Person

Within this role you will be responsible for providing expertise and leadership in the quality function. You will be responsible to ensure that licensed product is certified and released to market in compliance with commercial manufacturing license and clinical (IMP) products.As an Associate Director Qualified Person a typical day might include, but is not limited to, the following:Owning and continuously improving the batch disposition of quality in the Industrial Operations and Product Supply organization.Being responsible for disposition of medicinal product.Interacting with critical biotechnology commercial and clinical API and fill/finish manufacturing operations, facilities and quality control laboratories to ensure a successful compliance profile.Partnering with critical contract manufacturers to resolve compliance issues in clinical and commercial supply chains, interfacing with customer/partner quality organizations, and negotiating third party contractor and supplier quality agreements.Coordinating QA resources assigned to functional area to meet goals and timings; prioritization of activities with area management.Participating in cross functional teams as Quality/Qualified Person representative.Providing advice and direction to other company departments on quality and regulatory issues.Acting as an auditor on behalf of Regeneron Ireland.Involved in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensuring regulatory observations are adequately addressed and completed on schedule.Authorizing significant deviations to established, approved procedures, providing mentorship to assist co-workers with troubleshooting investigations and problem resolution.Ensuring safety and operational standards are maintained.This role might be for you if:You have 5 years work experience acting as Qualified Person, named on the Manufacturing and Importation Authorisation (MIA) license.You have expert knowledge of 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for medicinal products for human and veterinary use.You have the ability to research, analyze and extrapolate critical regulatory information.You are team-oriented and a positive relationship builder.You have an ability to optimally collaborate with a range of individuals across the organization at all levels.To be considered for this opportunity you should have a third level qualification (degree in science or related discipline preferred) appropriate for QP eligibility and a minimum of 8 years of related experience in the pharmaceutical and/or biotechnology industry. #J-18808-Ljbffr