Job Description
The Manager QA Validation is responsible for qualification of equipment, utilities, software, and validation of cleaning and sterilization processes in Regeneron's Raheen facility. A typical day might include, but is not limited to, the following: Designing and developing policies for validation and ensuring that they are effectively administered and comply with regulatory requirements Leading all aspects of QA validation including reviewing and approving 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 Managing Validation Department personnel by developing validation work plans, establishing objectives, and assigning tasks Developing and managing validation budget, contracts, and schedules Presenting and defending validation data to FDA and other regulatory agencies Maintaining validation document and software control system Ensuring 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 and prioritizing of activities with area management Playing a proactive role in developing and applying new approaches and processes to validation strategies Working with senior managers and executives to create a broad-based validation program. Appling complete functional knowledge and awareness of company goals and objectives Supporting employees work performance; conducts hiring and discharge interviews This role might be for you if: You have strong leadership and problem-solving skills, with the ability to empower and lead a team You are dedicated to quality improvement and the ability to handle pressure professionally Strong oral and written communication skills, with a focus on collaboration and stakeholder engagement You have solid understanding of Data Integrity You have strong understanding and application of GMP and regulatory requirements. To be considered for this position you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 7+ years of direct experience in validation of pharmaceutical or biopharmaceutical facilities and processes. You must also have a minimum of 2 years direct people management 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.