Job Description
The Associate Manager QA is responsible for all aspects of QA Team; provides leadership and support to direct reports and will provide QA oversight for Manufacturing Operations to ensure that drug substance manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. A typical day might include, but is not limited to, the following: Leading all aspects of the QA Team including review and approval of the following types of documents, relating to area functions: Master records / executed records / failure investigations / CC / SOPs / validation protocols and summary reports / incursions Approving various documents relating to area function, including those listed above Coordinating QA resource assigned to functional area to meet goals and timings; coordinates prioritization of activities with area management Performing compliance monitoring of area operations, including trending of failures and evaluating efficiency of corrective actions Reviewing customer requirements and implements required processes, as needed, to meet customer expectations regarding Quality Participating in regulatory and customer audits This role might be for you if: You are a dedicated leader who can train, mentor and lead employees across shift teams Previous experience as QA SME in highly regulated environment (e.g. pharma or biotech in both internal and external regulatory audits) You have the ability to maintain integrity and honesty at all times You are an expert GMP & GDP knowledge To be considered for this opportunity you should have a BS/BA in life sciences discipline or related field with minimum 7 years of experience in pharmaceutical or biologics manufacturing environment. A minimum of 3 years Supervisory and/or leadership experience essential. 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.