Director Qualified Person

Summary: 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 include, but are not limited to, the following :

• Owns and continuously improves the batch disposition of Quality in the Industrial Operations and Product Supply organization.
• 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
• Interacts with critical biotechnology commercial and clinical API and Fill/Finish manufacturing operations, facilities and Quality Control laboratories to ensure a successful compliance profile.
• 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.
• May organise QA resource assigned to functional area to meet goals and timings; coordinates prioritisation of activities with area management.
• Participates in cross functional teams as Quality/Qualified Person representative as required
• Provides advice and direction to other company departments on quality and regulatory issues
• Acts as an auditor on behalf of Regeneron Ireland
• Involved in aspects of Regulatory Agency interactions and preparation as related to site inspections, and ensures regulatory observations are adequately addresses and completed on schedule.
• Authorises significant deviations to established, approved procedures, provides guidance to assist co-workers with troubleshooting investigations and problem resolution.
• Ensures safety and operational standards are maintained.

Education and Experience:

• Third level qualification (degree in science or related discipline preferred) appropriate for QP eligibility
• 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.

#REGNIEQA #LI-Onsite #IREADV #JOBSIEST Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location. #J-18808-Ljbffr