Director, Quality Technical Operations

Build Our Future Together At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Director of Quality Technical Operations you will lead a high-impact Quality function spanning QA MES, QA Validation Oversight, and QA Tech Transfer. Youll define and implement cGMP best practices, set quality standards and metrics, and ensure clinical and commercial manufacturing operations meet and exceed regulatory compliance requirements. When & Where Location: Rensselaer, NY Work model: Monday-Friday, 8am-4:30pm Discover Your Role Define and implement quality standards, systems, and metrics across clinical and commercial manufacturing operations. Provide quality oversight to activities related to validation and ensure that they are effectively administered and comply with regulatory requirements. Oversee QA tasks related to electronic manufacturing record management and tech transfer. Compile, organize, and present quality metrics and trends to senior leadership. Plan and allocate QA resources to meet program goals, timelines, and priorities. Coordinate prioritization of activities with area management to optimize execution. Prepare for regulatory and customer audits; ensure observations are addressed effectively and on schedule. Maintain safety and operational standards and approve documents related to QA functions. This Role Requires Bachelors degree in Life Sciences, Engineering, or related field, or equivalent combination of education and experience, and the following amount of relevant work experience for each level: Director 12+ years Senior Director 15+ years Level will be determined based on experience Proven leadership in cGMP environments with hands-on experience in QA systems and metrics A track record of successful audit readiness, execution, and response management Strong collaboration, communication, and stakeholder engagement skills An understanding of bulk API biologics manufacturing operations We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit For other locations, additional information will be provided during the recruitment process. Many roles are required to be performed onsite. As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications. For jobs in Canada: this posting is for an existing position. Salary Range (annually) $172,200.00 - $338,400.00 #J-18808-Ljbffr BioSpace