Manager GCP Quality, Technology and Compliance

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 by overseeing how quality issues like deviations and CAPAs are captured, escalated, and resolved. Working across Clinical, Regulatory, and Medical Affairs 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.

A Typical Day :

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—within an electronic 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 enjoy training, supervising, and mentoring junior staff

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.