Associate Director, Quality (Bioanalytical Documentation Review)

Location: Tarrytown
Posted on: June 23, 2025

Job Description:

Regeneron's Quality Control group, located in Tarrytown NY, is seeking an Associate Director. In this exciting role you will be responsible for the oversight of independent QC support of Assay Development, Clinical and Nonclinical Bioanalysis, and Sample Management activities within Bioanalytical Sciences (BAS). A Typical Day in the role of an Associate Director Might Look Like: Demonstrate a mastery of technical and process-related knowledge to ensure that GxP principles, industry standards, and corporate policies are adhered to and properly applied with respect to the QC of data, documentation and reports. Demonstrate a sense of accountability related to QC activities and the associated findings generated. Is capable of applying independent judgment to make decisions regarding the quality of documentation and data. Independently evaluates and establishes QC processes with the overarching aim to improve the overall efficiency and quality of the work performed. Skilled in change management, routinely leading the implementation of solutions to troubleshoot complex problems and/or optimize processes that impact the QC group or QC sub-functions. Work collaboratively and cross-functionally with BAS Management, appropriate stakeholders and the Quality Assurance Unit (QAU) to improve the overall documentation quality and to maintain a high level of data integrity. Viewed as a collaborative partner who consistently shares information and knowledge with peers. Have direct supervisory responsibilities for multiple direct reports, including those responsible for leading sub-functions within QC. Provides leadership, guidance, and training to members of the QC group. This Role Might Be for You if You: Possess significant experience in ensuring the quality review of documentation and data. Are knowledgeable about industry guidelines and requirements associated with data compliance and quality. Are a strong collaborator and communicator that can work cross-functionally to achieve group and departmental objectives. Have experience leading a high performing team, and are capable of providing high-level oversight, guidance, and leadership. To be considered for this position, you must have a BS or MS degree with 15 years of relevant scientific experience or a PhD with 10 years of relevant scientific experience. Experience overseeing a quality function in support of bioanalytical, CMC, GMP, or similar activities is also required. BioanalyticalSciences QualityControl 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. Salary Range (annually) $154,800.00 - $252,800.00

Keywords: , Westfield , Associate Director, Quality (Bioanalytical Documentation Review), Science, Research & Development , Tarrytown, Massachusetts