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About the Role

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

Requirements

• BS/BA in Life Sciences or related field; or equivalent combination of education and experience
• Previous people leadership/supervisory experience
• Gowning: Full cleanroom attire (Examples may include: including 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

Skills

• Knowledge of visual inspection, assembly, labeling, and packaging operations is preferred

Location

• East Greenbush, New York, United States

Work Type

• On-site

Experience Level

• Associate Manager QA: 6+ years of relevant experience
• Manager QA 7+ years of relevant experience
• Level will be determined based on experience

Education Level

• BS/BA in Life Sciences or related field

Salary/Compensations

• $92,200.00 - $176,000.00

Benefits

• annual bonuses or other incentive plans
• equity awards
• pension or retirement benefits
• 401(k) company match
• health and wellness programs
• fitness centers
• insurance benefits (e.g. medical, dental, vision, life and disability)
• paid time off
• family support benefits

About the Company

• At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

Equal Opportunity

• Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
• Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.