Visual Inspection Program Lead

Regeneron Pharmaceuticals, Inc; Town of North Greenbush (NY); 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 across liquid and lyophilized injectable products.

You will drive inspection standards, defect classification, and regulatory alignment (USP, EU Annex 1, 21 CFR Part 211) while collaborating with Manufacturing Operations, QA, Regulatory, and Process Development to ensure every dose meets high quality standards.

Qualifications

• Bachelor’s degree in scientific or engineering discipline or related field required.
• 6+ years of manufacturing experience with prior supervisory experience or equivalent.
• Experience in a cGMP fill/finish environment with exposure to visual inspection program elements and regulatory requirements.

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

Cross-functional collaboration

Regulatory compliance

Quality systems

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 across liquid and lyophilized injectable products.

You will drive inspection standards, defect classification, and regulatory alignment (USP, EU Annex 1, 21 CFR Part 211) while collaborating with Manufacturing Operations, QA, Regulatory, and Process Development to ensure every dose meets high quality standards.