Manager GCP Quality, Technology and Compliance

Regeneron Ireland DAC; Dublin; On-site; EUR 70,000 - 90,000; Full time

Job summary

A leading biopharmaceutical company in Dublin seeks a Manager for GDQTC to oversee quality workflows and support an eQMS. Candidates should have at least 6 years of experience in the pharmaceutical industry and expertise in managing quality processes like deviations and CAPAs. Familiarity with the Veeva Quality Suite is preferred. This role combines quality ownership with continuous improvement in a fast-paced environment.

Qualifications

• At least 6 years of experience in the pharmaceutical or healthcare industry.
• Hands-on experience with quality issue management processes like deviations and CAPAs.
• Experience supporting GCP or GVP regulated processes.

Responsibilities

• Managing and triaging user requests via the Quality Support Mailbox.
• Coordinating eQMS system upgrades and changes.
• Supporting issue management workflows including deviations and CAPAs.

Skills

Quality workflows management

Cross-functional collaboration

GCP and/or GVP compliance

System lifecycle management

Analytical thinking

Education

Bachelor's degree

Tools

Veeva Quality Suite

Job description

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.