QMS Consultant & Veeva Vault Project Support AnalystRole OverviewWe are seeking a professional with expertise in Quality Management Systems (QMS) and Veeva Vault to support the implementation, migration, and optimization of quality management processes. This role will focus on document and data migration, regulatory compliance, system integration, and ongoing support for Veeva Vault applications.The candidate will work from 5:30 PM IST 2:30 AM IST to align with the US time zone.Key ResponsibilitiesQuality Management & ComplianceProvide subject matter expertise on Vault R&D migration and quality management.Ensure quality standards, GxP compliance, and regulatory requirements (e.g., ISO 9001) are met.Conduct risk assessments to identify compliance gaps and inefficiencies.Define document classification and approval workflows aligned with industry best practices.Develop, implement, and maintain standard operating procedures (SOPs) and workflows for quality management.Manage change control processes, ensuring minimal disruption to quality standards.Implement post-migration quality checks to ensure document integrity.Provide ongoing monitoring and support for quality management tools and systems integrated with Veeva Vault.Track quality metrics, risks, and issues in compliance reports.Veeva Vault Implementation & SupportAssist in migrating data and documents into Veeva Vault, ensuring accuracy and compliance.Collaborate with cross-functional teams to gather requirements and align migration activities with project goals.Provide technical expertise on Veeva Vault functionalities, workflows, integrations, and best practices.Conduct data quality checks post-migration to validate completeness and integrity.Troubleshoot technical issues and provide system support.Optimize automation, reporting, and regulatory compliance tracking within Veeva Vault.Communicate with both technical and non-technical teams to bridge business needs with system specifications.Identify, assess, and escalate potential risks related to migration and system integration.Training & Stakeholder EngagementDevelop and update training documents and job aids for new Veeva Vault practices.Work alongside the Training & Procedures Team to provide comprehensive end-user training.Conduct product demonstrations and stakeholder engagement sessions to ensure seamless adoption.Gather and address stakeholder feedback to improve system functionalities and compliance adherence.Required Skills & ExperienceTechnical & Functional Expertise3+ years of experience in Veeva Suite, Veeva Vault, and Quality Management Systems (QMS).Prior experience with Veeva migration support, data/document migration, and metadata mapping.Experience working with Veeva Vault Quality Suite, including workflows, document types, reports, dashboards, and notifications.Strong understanding of GxP, ISO 9001, and software validation regulations.Hands-on experience in testing, script execution, and system troubleshooting.Experience in configuring and resolving issues in multiple Veeva Vaults.Soft Skills & QualificationsVeeva Admin Certification is required.Bachelors degree in life sciences, computer science, or a related field.Strong analytical, problem-solving, and attention to detail skills.Excellent communication and interpersonal skills to work collaboratively across teams.Ability to influence stakeholders and manage change control processes effectively.Highly organized and detail-oriented with strong documentation skills.This role is ideal for candidates who can blend technical expertise with quality management practices while ensuring seamless regulatory compliance, data integrity, and system optimization within Veeva Vault.
