Job Description
Within this role you will be responsible for all aspects of the assigned QA team providing leadership and support to direct reports and providing QA oversight to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement. As an Associate Manager/Manager QA (MES & Projects), a typical day may include, but is not limited to, the following: Leading all aspects of QA Team such as reviewing and approving the following types of documents, relating to area functions: master records, executed records, failure investigations, change control, SOPs, validation protocols and summary reports Approving various documents relating to area function including those listed above Coordinating QA resources assigning to functional area's to meet goals and timings; coordinating prioritization of activities with area management Performing compliance monitoring of operations, including trending of failures and evaluating efficiency of corrective actions Reviewing customer requirements and implementing required processes, as needed, to meet customer expectations regarding quality Participating in internal, regulatory and customer audits Identifying opportunities for improvement in the QA program and processes Leading the planning and execution of QA and projects with a focus on digital transformation, within regulatory guidelines, working closely with cross-functional teams, using excellent communication and project management skills Building and maintaining positive relationships with a wide variety of internal and external partners Ensuring teams and partners are aligned on project plan, plans and tracking project activities, providing contingency and risk mitigation planning for projects This role might be for you if: You have strong project management skills You are a dedicated leader that can develop growing teams You have the ability to identify continuous improvement needs You have an understanding of MES You have experience in understanding and interpreting regulatory guidelines and documents You have a strong Quality mindset To be considered for this opportunity you must have a Bachelor's degree in a Science/Quality/Engineering discipline or related field with minimum 7+ years of experience in pharmaceutical or biologics manufacturing environment. Relevant experience may be considered in lieu of the educational requirement. MES experience is advantageous. Supervisory and/or leadership experience is essential. Associate Manager: 7+ years of relevant experience / Manager: 8+ years of relevant experience. 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. 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.