Manager Quality Assurance (On the floor)

Regeneron Pharmaceuticals•Rensselaer, NY

10d•$92,200 - $176,000•Onsite

About The Position

This operational position is responsible for the leadership, development, and oversight of the QA team supporting visual Inspection, assembly, labeling, and packaging operations performed at Regeneron’s internal Fill/Finish facility.

Requirements

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

Nice To Haves

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