Quality Control Business Systems Analyst

Regeneron Pharmaceuticals, Inc.; New York (NY); On-site; USD 62,000 - 131,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. seeks a QC Business Analyst (Associate through Senior level) to join the IOPS Quality Control team, translating QC IT needs into viable solutions and coordinating QC IT projects across LIMS, ELN, SDMS, and Empower platforms.

You will lead cross-functional teams, define priorities, and serve as a bridge between QC operations and the IOPS IT group—while collaborating with QC functional areas, IT, Validation, and end users.

Qualifications

• BS/BA in a related field.
• Associate Business Analyst – QC: 0–2 years of relevant laboratory and/or database/LIMS experience
• Business Analyst – QC: 2+ years of relevant laboratory and/or database/LIMS experience
• Senior Business Analyst – QC: 5+ years of relevant laboratory and/or database/LIMS experience; level determined based on qualifications
• Experience with LabWare LIMS or another LIMS platform; super-user or administrative role experience preferred
• Familiarity with electronic lab management systems and quality compliance requirements in a regulated environment

Responsibilities

• Define IT requirements and lead QC IT projects; coordinate cross-functional teams to prioritize QC IT initiatives
• Coordinate QC functional area needs and establish priorities for LIMS configurations and test method templates
• Execute tasks related to support and management of QC-owned software including LIMS, ELN, and SDMS; approve and own change controls
• Partner with IT on User Requirement Specifications and test plans; work with users and vendors to implement features
• Provide administrative and compliance support for computerized systems including QUMAS, ELN, SDMS, and Empower
• Write and revise SOPs, URS, and FRS; ensure compliance with SOPs and formats
• Provide training and support to QC end users; manage timeline and escalate as needed

Skills

Cross-functional teamwork

Regulatory/compliance

IT systems knowledge

LIMS/ ELN familiarity

Education

BS/BA in related field

Associate Business Analyst – QC: 0–2 years

Business Analyst – QC: 2+ years

Senior Business Analyst – QC: 5+ years

Tools

LabWare LIMS

ELN

SDMS

Empower

Job description

Team: Industrial Operations & Product Supply

Quality Control Business Systems Analyst

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a QC Business Analyst (Associate through Senior level) to join our IOPS Quality Control team, translating QC IT needs into viable, cutting-edge solutions and coordinating QC IT projects across LIMS, ELN, SDMS, and Empower platforms. In this role, you will lead cross-functional teams, define priorities, and serve as the bridge between QC operations and the IOPS IT group — while collaborating with QC functional areas, IT, Validation, and end users. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Discover your role:

• Remain aware of QC needs, define corresponding IT requirements, and develop IT solution proposals; lead cross-functional teams to define and prioritize QC IT projects and initiatives
• Coordinate QC functional area needs and establish priorities for LIMS configurations including implementation of new specifications, design of templates for new and revised test methods, and development of queries and reports
• Execute tasks related to the support and management of QC-owned software including LIMS, ELN, and SDMS; approve, process, and own change controls and account change requests
• Partner with the IT group on projects including User Requirement Specifications and coordination, execution, and development of test plans; work with users and vendors to define and implement system features and improvements
• Provide administrative and compliance support for computerized systems including QUMAS, ELN, SDMS, and Empower; support inspection and compliance activities including business system ownership
• Write and revise SOPs, User Requirement Specifications, and Functional Requirement Specifications; review documents to ensure consistency with SOPs and current formats
• Provide training and support to QC end users; elevate priority conflicts or project timeline delays to QC management as needed

This role requires:

• BS/BA in a related field
• Associate Business Analyst – QC: 0–2 years of relevant laboratory and/or database/LIMS experience
• Business Analyst – QC: 2+ years of relevant laboratory and/or database/LIMS experience
• Senior Business Analyst – QC: 5+ years of relevant laboratory and/or database/LIMS experience; level determined based on qualifications
• May consider equivalent combination of education and experience; level determined based on qualifications
• Experience with LabWare LIMS or another LIMS platform; super-user or administrative role experience preferred
• Familiarity with electronic lab management systems and quality compliance requirements in a regulated environment

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.

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)

$62,355.00 - $131,300.00

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