Director, Quality Technical Operations

Director Of Quality Technical OperationsAt Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. You will lead a high-impact Quality function spanning QA MES, QA Validation Oversight, and QA Tech Transfer. You'll define and implement cGMP best practices, set quality standards and metrics, and ensure clinical and commercial manufacturing operations meet and exceed regulatory compliance requirements.Location: Rensselaer, NYWork model: Monday-Friday, 8am-4:30pmDefine 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.Bachelor's 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+ yearsSenior Director – 15+ yearsLevel will be determined based on experienceProven leadership in cGMP environments with hands-on experience in QA systems and metricsA track record of successful audit readiness, execution, and response managementStrong collaboration, communication, and stakeholder engagement skillsAn understanding of bulk API biologics manufacturing operations