Lead Visual Inspection Program: On-Site Quality Innovator

BioSpace; Town of East Greenbush (NY); On-site; USD 92,000 - 151,000; Full time

Job summary

Regeneron is seeking a Visual Inspection Associate Program Manager in Rensselaer, NY to lead the site inspection program and drive quality across liquid and lyophilized products. The role collaborates with Manufacturing Operations, QA, Regulatory, and Process Development to ensure top-tier product quality.

The ideal candidate has a Bachelor's degree in a scientific field and 6+ years in manufacturing with supervisory experience, plus experience in a cGMP environment and a track record of

Qualifications

• Bachelor's degree in scientific or engineering discipline required.
• 6+ years of manufacturing experience, with supervisory responsibilities.
• Experience in a cGMP fill/finish environment preferred.
• Demonstrated leadership in managing technical teams within a regulated setting.

Responsibilities

• Leads the Visual Inspection Technical Services team and Defect Creation Lab.
• Owns the visual inspection program strategy, standards, and defect criteria for liquid and lyophilized injectable products.
• Ensures inspection processes meet USP, EU Annex 1, 21 CFR Part 211, and ICH/PDA guidance.
• Drives KNAPP/test sets and defect libraries for operator and equipment qualification.
• Monitors KPIs and trends to guide data-driven continuous improvement.
• Collaborates with Manufacturing, QA, Regulatory, Process Development, and EHS on inspection processes and quality.
• Evaluates emerging inspection technologies including AI/ML-based detection for program innovation.
• Manages and develops team members while maintaining cGMP and GDP compliance.

Skills

Visual inspection

Regulatory compliance

Leadership

Project management

Education

Bachelor's degree in scientific discipline

Job description

Regeneron is seeking a Visual Inspection Associate Program Manager in Rensselaer, NY to lead the site inspection program and drive quality across liquid and lyophilized products. The role collaborates with Manufacturing Operations, QA, Regulatory, and Process Development to ensure top-tier product quality.

The ideal candidate has a Bachelor's degree in a scientific field and 6+ years in manufacturing with supervisory experience, plus experience in a cGMP environment and a track record of