Job Description
This position implements policies and procedures to review and approve validation/qualification documentation for equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards, and oversees a team of Validation Oversight Specialists. As an Associate Manager in QA Validation Oversight a typical day might include, but is not limited to, the following: Leading a technical quality review team by developing appropriate plans & schedules, resource loading, developing validation best practices, standards and guidelines Reviewing and approving validation protocols and summary reports generated by the validation staff against standard operating procedures and policies as well as providing guidance to validation staff that execute protocols and draft associated deviations and final reports Approving various documents relating to area function, including those listed above Providing direction and assigning work to Validation Oversight Specialists to meet goals and timings Coordinating prioritization of activities with area management Participating in regulatory and customer activities Collaborating with functional departments to resolve issues Managing projects and preparing status reports This role might be for you if: You are a self-starter with the ability to operate in a multifaceted environment, able to work on your own initiative and within a team environment You have strong organisational and project management abilities and demonstrate good attention to detail You have strong technical knowledge in drug product manufacturing, product development and validation You possess knowledge of industry practices and regulations You have the ability to maintain integrity and honesty at all times You are a dedicated people leader with the ability to mentor, train and lead employees To be considered for this opportunity you should have a BS/BA in Engineering, Chemistry, or Life Sciences with a minimum of 7+ years of related experience within the field; may consider substituting relevant experience for education. Experience leading, supervising, or managing others required. #JOBSIEPR #REGNIEQA 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.