Job Description
**Regeneron Associate Director Qualified Person** **Summary:** Lead quality function, ensure licensed product certification and release, and provide expertise in quality and regulatory issues. 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. **Key Responsibilities:** • Own and continuously improve the batch disposition of quality in the Industrial Operations and Product Supply organization • Be responsible for disposition of medicinal product • Interact with critical biotechnology commercial and clinical API and fill/finish manufacturing operations, facilities and quality control laboratories to ensure a successful compliance profile • Partner 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 • Coordinate QA resources assigned to functional area to meet goals and timings; prioritization of activities with area management • Participate in cross functional teams as Quality/Qualified Person representative • Provide advice and direction to other company departments on quality and regulatory issues • Act 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 • Authorise significant deviations to established, approved procedures, provides mentorship to assist co-workers with troubleshooting investigations and problem resolution • Ensure 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:** • 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