Job Summary
This role requires expertise and leadership in the quality function, ensuring licensed products are certified and released to market in compliance with commercial manufacturing licenses and clinical products.
Main Responsibilities
* Owning and continuously improving batch disposition of quality in Industrial Operations and Product Supply organization.
* Responsible for disposition of medicinal product.
* Interacting with biotechnology commercial and clinical API and fill/finish manufacturing operations, facilities, and quality control laboratories to ensure successful compliance profiles.
* 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 areas to meet goals and timings; prioritizing 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 related to site inspections, ensuring regulatory observations are adequately addressed and completed on schedule.
* Authorizing significant deviations to established approved procedures, providing mentorship to assist coworkers with troubleshooting investigations and problem resolution.
* Ensuring safety and operational standards are maintained.
Requirements
* 5 years of work experience acting as Qualified Person, named on the Manufacturing and Importation Authorization (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 positive relationship builder.
* Ability to optimally collaborate with a range of individuals across the organization at all levels.
Qualifications
* Third-level qualification (degree in science or related discipline preferred) appropriate for QP eligibility.
* Minimum of 8 years of related experience in the pharmaceutical and/or biotechnology industry.