Manager, QA (Internal Validation Oversight) Position Available In Rensselaer, New York

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Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
May 23, 2025
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Company
Job Details At Regeneron, we are seeking a Manager, QA (Internal Validation Oversight) to lead a team dedicated to ensuring the integrity of our validation processes. In this role, you will be responsible for the oversight of qualification of equipment, utilities, software, and validation of cleaning and sterilization processes, as well as playing a key role in regulatory inspections. In this role, a typical day might include the following: Designing and developing policies related to validation and ensuring that they are effectively administered and aligned with regulatory requirements. Being responsible for all aspects of QA Validation including review and approval of the following types of documents, relating to area functions: Failure investigations Change controls and associated Test Plan documentation SOPs Validation protocols and summary reports Validation Master Plans Leading Validation team by developing validation work plans, establishing objectives, and assigning tasks. Developing and managing validation budget, contracts, and schedules. Presenting/defending validation data to FDA and other regulatory agencies. Maintaining validation document and software control system while ensuring that validation status is maintained for equipment and software use in commercial and clinical manufacturing. Organizing QA Validation resource assigned to functional area to meet goals and timings; coordinating prioritization of activities with area management. Interacting with senior managers and executives to create a broad-based validation program. This role might be for you if you: Bring hands-on validation experience in a GMP-regulated environment. Build strong, collaborative relationships across teams and with external partners while delivering exceptional customer service. Have a continuous improvement mentality to identify and implement improvement opportunities. Are an experienced leader who knows how to inspire and guide a multi-tiered team. To be considered for this role you must hold a Bachelors degree in Engineering, Chemistry, or Life Sciences with a minimum of 7 years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes. #REGNQA Does this sound like you? 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. Salary Range (annually) $106,400.00 – $173,400.00
Company Regeneron is a leading biotechnology company that invents, develops, and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

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