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Director Qualified Person

3 months ago

Ireland Regeneron Pharmaceuticals, Inc Full time

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 step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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