Manager Quality Assurance (On the floor)

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

Build our future together: At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

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.

When & where:

Location: East Greenbush, New York, United States Work model, available shifts: Monday-Friday, 8am-4:30pm Monday-Thursday, 2-10:30pm

Discover your role:

• 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 rhythms of the role:

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

This role requires:

• 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

Does this sound like you?

We are committed to building a workplace with an inclusive culture. 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. Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

If you have any questions, please speak with your recruiter.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position. Salary Range (annually) $92,200.00 - $176,000.00

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.