Manager GCP Quality, Technology and Compliance

Overview

We’re looking for a quality-minded systems expert to help shape how regulated processes are managed across Global Development. As Manager, GDQTC, you’ll support our Veeva Quality Suite-based eQMS which manages the quality events, actions and audits of our Global Development organization. Working across Clinical, Regulatory, and IT teams, you’ll ensure the eQMS continues to meet the needs of a complex, fast-evolving environment. This role offers the opportunity to blend quality process ownership with system-level thinking—driving meaningful improvements in how we maintain GCP and GVP compliance across Regeneron’s global development operations.

Responsibilities

• Managing and triaging user requests via the Quality Support Mailbox
• Coordinating eQMS system upgrades and configuration changes with Global Development IT
• Supporting issue management workflows including deviations, CAPAs, investigations, and change controls
• Gathering and refining business requirements to guide system enhancements
• Creating dashboards, storyboards, and reports for audit readiness and quality oversight
• Liaising with stakeholders across Clinical, Regulatory, Medical, and Quality functions
• Ensuring adherence to SDLC principles and validation expectations for all system changes
• Identifying and driving process improvements tied to system use, support, and compliance

This Role May Be For You

• You’ve managed or owned quality workflows—like deviations and CAPAs—withinelectronic QMS
• You’re adept at managing the full system lifecycle, from implementing new features to overseeing data standards and vendor performance
• You’re familiar with the Veeva Quality Suite, especially QualityDocs and QMS modules
• You bring hands-on experience with GCP and/or GVP-regulated processes
• You’re a strong communicator who enjoys cross-functional collaboration and stakeholder engagement
• You thrive in structured environments and bring rigor to how systems and data are handled
• You’ve supported system changes under regulated SDLC practices (validation, change control, etc.)
• You enjoy working at the intersection of quality, technology, and operations
• You’re analytical and enjoy using data to inform decisions and improvements

To Be Considered

You’ll need a bachelor’s degree and at least 6 years of experience in the pharmaceutical or healthcare industry. The ideal candidate has supported quality issue management processes—such as deviations, CAPAs, and investigations—within a GCP or GVP setting. Experience with the Veeva Quality Suite (especially QualityDocs and QMS modules) is strongly preferred, and formal Veeva Vault Platform certifications (e.g., White/Gray Belt) are highly desirable. Familiarity with related clinical systems is a bonus.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company\’s business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.