Manager Quality Assurance (On the floor)

About the role

We are seeking a Manager to join our Quality Assurance (QA) on the floor team. 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.

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

The Environment and Physical Requirements of the Role

• Gowning: Full cleanroom attire (Examples may include: laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

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
• Level will be determined based on experience
• Previous people leadership/supervisory experience
• Knowledge of visual inspection, assembly, labeling, and packaging operations is preferred

Work model and available shifts:

• Monday–Friday, 8:00 am–4:30 pm
• Monday–Thursday, 2:00 pm–10:30 pm

Pay

Salary range (annually): $92,200.00 – $176,000.00