Manager Gcp Quality, Technology And Compliance
5 days ago
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.
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 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.
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.
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Manager Gcp Quality, Technology And Compliance
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Dublin, Dublin City, Ireland Regeneron Ireland DAC Full timeWe'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 e QMS by overseeing how quality issues like deviations and CAPAs are captured, escalated, and resolved.Working across Clinical, Regulatory, and Medical Affairs teams,...
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Dublin Pike, Ireland Regeneron Ireland DAC Full timeWe'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...
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