Senior Quality Assurance Specialist, Material Supplier

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in New York seeks a Senior Quality Assurance Specialist, Material Supplier to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality and compliance.

The role provides global coordination for supplier change notifications, supports CAPAs, maintains controlled documents, and drives improvements in the Material & Supplier Quality program. On-site in Rensselaer, NY.

Qualifications

• Bachelor’s degree in scientific subject area or related field required.
• Experience coordinating supplier change notifications and deviations.
• GMP environment experience preferred and regulatory inspections support helpful.

Responsibilities

• Reviews and coordinates Supplier Change Notifications across global suppliers, including intake, triage, risk assessment, and closure.
• Supports resolution of internal and external deviations.
• Maintain and update controlled documents related to supplier change notification.
• Supports execution of CAPAs arising from supplier changes, audits, or process gaps.
• Gathers and provides information to support regulatory inspections and audits.
• Improves Material & Supplier Quality program to reduce cycle times and improve right-first-time.
• Manages and tracks projects to meet milestones within timelines.
• Experience partnering with GMP material/component suppliers.

Skills

GMP experience

Supplier Change Notifications

CAPA execution

Education

Bachelor’s degree in scientific subject area or related field

Job description

Build our future together: Our Material & Supplier Quality Assurance team is hiring a Senior Quality Assurance Specialist, Material Supplier to lead end-to-end management of supplier-initiated changes to GMP materials and components, safeguarding product quality, compliance, and supply. This role provides global coordination for supplier change notifications.

When & where:

Location: Rensselaer, New York, United States

Work Model: Monday - Friday, 8:00 AM to 4:30 PM

Discover your role:

• Reviews and coordinates Supplier Change Notifications across global suppliers, including intake, triage, risk assessment, cross functional impact evaluation, communication, and closure.
• Supports the resolution of internal and external deviations
• Maintain and update-controlled documents related to supplier change notification.
• Supports execution of Corrective/Preventative Actions (CAPAs) arising from supplier changes, audits, or process gaps.
• Gathers, evaluates and provides information/documentation to support regulatory inspections and inquiries, as well as partner and internal audits.
• Performs continuous improvement of the Material & Supplier Quality program with a focus on SCN workflow efficiency, cycle time reduction, and right first time.
• Manages and tracks projects to ensure milestones are achieved while complying with established timelines.
• Experience partnering with suppliers of GMP materials/components preferred.
• Previous quality experience in a GMP environment.

This role requires:

• Bachelor’s degree in scientific subject area or related field and the following years of experience for each level: Specialist: 2+ years Sr. Specialist: 5+ years May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

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.

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.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $67,400.00 - $128,700.00

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.

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.