Within this role you will act in the capacity of a Qualified Person in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of Regeneron products.
A typical day might include, but is not limited to, the following:
Running the batch disposition process ensuring timely release of Regeneron products
Ensuring the batch disposition process maintaining compliance with site practices & regulatory requirements
Depositing of Regeneron products 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
Supporting major investigations, ensuring all product deviations are closed prior to batch release
Reviewing and approving Product Quality Reviews
Reviewing and approving new and revised master manufacturing records
Participating in cross functional teams as Quality/Qualified Person representative
Participating in third party/supplier audits, as required
Providing additional QP support to quality related issues, as required
Working with customer/partner quality organizations
Participating on internal committees/teams, as required
Providing advice and direction to other company departments on quality and regulatory issues
Providing audit expertise and conduct audits on behalf of Regeneron Ireland
Contributing to the establishment of EU QP Release function for Regeneron products
Supervising of direct reports
To be considered for this opportunity you should have a MSc appropriate for QP eligibility, with a minimum of 8+ years of relevant work experience that provides the knowledge, skills, and abilities to perform the QP job or equivalent combination of education, training, & experience.
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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.