Director, External Manufacturing Compliance We are currently looking to fill a Director of External Manufacturing Compliance position. This role will supervise a team that supports compliance activities for all products manufactured in Regeneron’s External Manufacturing network, in accordance with regulatory requirements, Regeneron Quality Systems, and site expectations. This position is located at our Manufacturing facility in the Albany, NY area and is a fully onsite role. Responsibilities Provide leadership and support to prioritize, resource, guide, strategize and deliver upon compliance requirements Establish standard processes in all compliance related activities; collaborate with quality compliance groups; strategically meet goals and lead External Manufacturing cGMP policies and SOPs Lead and prioritize operations and practices for supporting CMO and/or Partner Change Notifications, Change Controls, SCARs, Deviations, and CAPAs for clinical and commercial manufacturing across External Manufacturing Provide performance metrics status and continuous improvement needs to CMOs at regular Operations Steering Committees Be responsible for Inspection Readiness strategies related to regulatory inspections or quality audits involving outsourced manufacturing; provide advice and on-site support to CMO/Partner sites during regulatory activity and support internal Regeneron audits Provide expertise to the global External Manufacturing organization on cGMP compliance standard processes, and on new and developing cGMP regulatory requirements and trends Develop, train and coach Compliance and Manufacturing Specialists to lead or support closure of Quality System records Collaborate with Quality Assurance and External Manufacturing teams to address observations and drive CAPAs, SCARs, CCs to completion Travel up to 40% (domestic and international) Qualifications and Skills Demonstrate a proactive approach to issue resolution with the ability to work across various departments and with business partners Excellent interpersonal, cross-cultural, communication and problem-solving skills Experience interacting withContract Manufacturing Organizations and leading in the Compliance/QA/QC field Knowledge of industry practices and regulations (cGMP, Annex I) and across multiple health authorities (e.g., FDA, EMA, MHRA) Leadership experience with a focus on team growth and staff development Proficiency in German, French and/or Spanish (oral and written) is a plus Role Requirements To be considered for this role you must hold a Bachelor's degree and the following amount of pharmaceutical aseptic manufacturing experience in compliance, quality assurance, or manufacturing-related roles, for each level: Director – 12+ years Sr Director – 15+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role. Compensation and Benefits Salary range: $200,000.00 - $333,400.00 annually. 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 a protected class, sexual orientation, disability, or any other protected characteristic in accordance with applicable laws and regulations. The Company will provide reasonable accommodation to 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. Note: Background checks will be conducted in accordance with applicable law. Salary ranges shown apply to U.S.-based positions; for roles outside the U.S., Japan, or Canada, please discuss with your recruiter. Additional Information Seniority level: Director Employment type: Full-time Job function: Management and Manufacturing Industries: Biotechnology

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