Principal Veeva Vault Quality Systems Architect

YPrime

Malvern (Chester County)

On-site

USD 180,000 - 230,000

Full time

44 hours ago

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Job summary

YPrime is seeking a Principal Quality Systems Engineer to lead the Veeva Vault Quality ecosystem (QualityDocs, Training, eQMS) in Malvern, PA. You will own the roadmap, governance, configuration, and continuous improvement of quality systems, ensuring compliance with GxP and 21 CFR Part 11 while collaborating with Quality, Compliance, IT, and business stakeholders.

Responsibilities include defining future-state processes, validating system activities, and driving data integrity through quality

Qualifications

Bachelor's degree in Business, Information Systems, Life Sciences, Quality, Engineering, or a related field, or equivalent professional experience.
10+ years of experience in a regulated pharmaceutical, biotechnology, medical device, CRO, or GxP environment.
5+ years of experience administering, configuring, or owning Veeva Vault Quality applications.
Experience implementing, expanding, or optimizing Veeva Vault platforms.
Experience supporting system migrations, data remediation initiatives, or platform consolidations.
Experience developing quality reporting, analytics, and dashboard solutions.
Experience working with integrations, workflow automation tools, or related technologies.
Experience utilizing Agile methodologies and Atlassian software.
Familiarity with inspection readiness programs and regulatory or client audits.
Veeva Vault Administrator Certification and/or Veeva Quality Suite Certification preferred.
Ability to travel as business needs dictate.

Responsibilities

Serve as the primary business owner and subject matter expert for Veeva Vault Quality applications, including QualityDocs, Training, and eQMS.
Develop and maintain the long-term roadmap for YPrime's quality systems platform.
Establish governance standards for system configuration, workflows, metadata, document classes, roles, permissions, and lifecycle management.
Evaluate new Veeva functionality, releases, and enhancements and recommend adoption strategies.
Partner with stakeholders to gather, document, and prioritize business requirements.
Analyze existing processes and identify opportunities for automation, standardization, simplification, and risk reduction.
Lead cross-functional workshops to define future-state processes and system solutions.
Configure and maintain document lifecycles, workflows, training curricula, user roles, security models, dashboards, reporting solutions, metadata structures, and business automation.
Support Veeva release cycles through impact assessments, testing, validation activities, and deployment readiness.
Enhance training assignment processes, curriculum management, and learner experiences within Vault Training.
Drive continuous improvement of quality workflows, including deviations, CAPAs, change controls, and related quality processes.
Support validated system activities, including impact assessments, change evaluations, user acceptance testing, and release readiness efforts.
Ensure compliance with GxP requirements, data integrity principles, 21 CFR Part 11 regulations, and company procedures.
Serve as the primary liaison with Veeva and other system vendors, coordinating support, enhancements, and issue resolution activities.
Partner with IT and business system owners to ensure successful integration and interoperability across platforms.
Develop and maintain quality metrics, dashboards, and operational reporting.
Analyze system performance, user adoption, training compliance, workflow effectiveness, and quality trends to provide actionable business insights.