About YPrime
At YPrime, we pioneer solutions that streamline the clinical trial journey, increasing certainty from study design to data lock. With a foundation built on decades of industry insight and expertise, we are inspired by the life-altering outcomes unlocked by clinical trials. Our dedication to quality is pivotal in propelling the groundbreaking endeavors of our partners, researchers, and investigators. With a technology platform that enables speed, flexibility, and certainty for large and emerging pharma companies alike, we provide eConsent, eCOA, IRT, and patient engagement solutions that solve with certainty in clinical research.
About the Role
The Principal Quality Systems Engineer serves as the business owner and strategic leader for YPrime's Veeva Vault Quality ecosystem, including QualityDocs, Training, and eQMS. This highly visible role is responsible for driving the roadmap, governance, configuration, and continuous improvement of YPrime's quality systems while ensuring compliance with GxP and 21 CFR Part 11 requirements. Working closely with Quality, Compliance, IT, and business stakeholders, you'll translate business needs into scalable system solutions, optimize quality processes, support validated system activities, and maximize the value of YPrime's investment in Veeva Vault.
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.
Skills
- Expert-level knowledge of Veeva Vault QualityDocs and Veeva Vault Training.
- Strong understanding of Veeva Vault eQMS, document control, audits, change control, and GxP compliance requirements.
- Experience administering and configuring enterprise quality systems within regulated environments.
- Experience gathering requirements, developing user stories, troubleshooting issues, and performing business analysis.
- Experience supporting validated systems and software lifecycle management.
- Strong knowledge of quality system governance, process improvement, and change management principles.
- Excellent written and verbal communication skills.
- Strong facilitation, stakeholder management, and problem-solving abilities.
- Ability to influence cross-functional teams and drive organizational adoption of new solutions.
- Experience with APIs, system integrations, automation tools, or technical testing platforms preferred.
- Familiarity with tools such as Postman, Selenium, Python, or similar technologies preferred.
- Experience working in Agile environments utilizing Atlassian tools and methodologies.
Education & Experience
- 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.
