Job Description
Welcome to the Associate Director Qualified Person role at our company.
Responsibilities
* Owning and continuously improving batch disposition of quality in Industrial Operations and Product Supply organization.
* Ensuring medicinal product disposition and compliance with regulations.
* Interacting with biotechnology commercial and clinical API and fill/finish manufacturing operations, facilities, and quality control laboratories for successful compliance profile.
* Partnering with 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.
Requirements
* 5 years work experience acting as Qualified Person, named on the Manufacturing and Importation Authorisation (MIA) license.
* 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.
* Ability to research, analyze, and extrapolate critical regulatory information.
* Team-oriented and a positive relationship builder.
* Ability to optimally collaborate with a range of individuals across the organization at all levels.
Qualifications
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.