QA Operations Manager - Fill/Finish, Onsite

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 100,000 - 180,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc on the East Greenbush, NY site is seeking a Manager to lead the Quality Assurance on the floor team supporting visual inspection, assembly, labeling, and packaging operations in Regeneron’s Fill/Finish facility.

The role requires strong people leadership, regulatory knowledge, and hands-on oversight to ensure compliant, high-quality manufacturing. On-site work with shift flexibility and a focus on process improvement and training.

Qualifications

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience.
• Associate Manager QA: 6+ years of relevant experience
• Manager QA: 7+ years of relevant experience
• Previous people leadership/supervisory experience
• Knowledge of visual inspection, assembly, labeling, and packaging operations is preferred

Responsibilities

• Manage direct reports, including performance management
• Provide first response for quality and compliance issues encountered on the manufacturing floor
• Lead, set expectations, schedule, and monitor performance standards and goals of assigned team(s) to ensure optimal performance
• Ensure teams possess the required skills and knowledge, and are appropriately trained, to support plant operations
• Ensure compliance with all regulatory requirements and good documentation practices to provide a safe, quality, and effective product
• Represent Quality function and speak to area processes and responsibilities in regulatory inspections
• Monitor and update area procedures to ensure alignment with policies and operational requirements to ensure quality standards are maintained
• Represent Quality Assurance in support of Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution
• Review, edit, or approve Regeneron controlled documents; may review or approve master batch records in electronic execution system
• Influence standards, challenge the status quo, and influence others to achieve results
• May oversee and administer visual inspection training and qualification programs

Skills

People leadership

Quality Assurance

Regulatory compliance

Performance management

Education

BS/BA in Life Sciences or related field

Job description

Regeneron Pharmaceuticals, Inc on the East Greenbush, NY site is seeking a Manager to lead the Quality Assurance on the floor team supporting visual inspection, assembly, labeling, and packaging operations in Regeneron’s Fill/Finish facility.

The role requires strong people leadership, regulatory knowledge, and hands-on oversight to ensure compliant, high-quality manufacturing. On-site work with shift flexibility and a focus on process improvement and training.