Visual Inspection Program Lead - Quality & Innovation

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc in Rensselaer, NY is seeking a Visual Inspection Associate Program Manager to lead the site’s visual inspection program, ensuring regulatory compliance and high product quality in fill/finish operations. The role collaborates with Manufacturing Operations, QA, Regulatory, and Process Development to drive continuous improvement.

The ideal candidate has a Bachelor's degree in a scientific or engineering field and 6+ years of manufacturing experience, including

Qualifications

• Bachelor's degree in scientific or engineering discipline with 6+ years of manufacturing experience, including prior supervisory experience or equivalent combination of education and experience.
• Experience in a cGMP fill/finish environment with exposure to visual inspection program elements.
• Demonstrated leadership experience managing technical teams within a regulated manufacturing environment.

Responsibilities

• Leads the Visual Inspection Technical Services team and Defect Creation Lab, building a culture of quality and continuous improvement
• Owns the site’s visual inspection program strategy, standards, and defect classification/acceptance criteria for liquid and lyophilized injectable products
• Ensures inspection processes and documentation meet USP <1790>, EU Annex 1, 21 CFR Part 211, and applicable ICH/PDA guidance
• Drives development of KNAPP/test sets and defect libraries used for operator and equipment qualification
• Monitors and trends program KPIs, such as defect detection and false reject rates, to guide data-driven continuous improvement
• Partners cross-functionally with Manufacturing, QA, Regulatory, Process Development, and EHS on inspection processes, equipment, and product quality
• Evaluates emerging inspection technologies, including automated and AI/ML-based detection, to drive program innovation
• Manages, coaches, and develops team members while maintaining cGMP and GDP compliance across the program

Skills

Leadership

Team management

Regulatory compliance

Quality assurance

Education

Bachelor's degree in scientific or engineering discipline

Job description

Regeneron Pharmaceuticals, Inc in Rensselaer, NY is seeking a Visual Inspection Associate Program Manager to lead the site’s visual inspection program, ensuring regulatory compliance and high product quality in fill/finish operations. The role collaborates with Manufacturing Operations, QA, Regulatory, and Process Development to drive continuous improvement.

The ideal candidate has a Bachelor's degree in a scientific or engineering field and 6+ years of manufacturing experience, including