Quality System Specialist (Veeva eQMS Specialist)

Essentials Duties And Responsibilities

• Lead or support different implementation phases of Veeva Basics modules and processes including Quality Docs, Quality Events, Supplier Quality, supporting SOPs and training
• Configure and optimize workflows, document types, metadata, training assignments, quality processes, and user roles
• Conduct detailed process mapping of current-state and future-state eQMS processes (e.g., Document Management, Change Control, Deviations, CAPA, Complaints, Training)
• Facilitate workshops with cross-functional stakeholders for training on new processes within Veeva
• Identify opportunities for process improvements and automation within Veeva
• Maintain updates to Veeva releases, including impact assessments and SOP revisions
• Develop user training materials and deliver hands-on training for business end users
• Provide ongoing support, troubleshoot issues, and manage enhancement requests
• Serve as a subject matter expert (SME) for Veeva Basics within the Quality organization
• Maintain and manage controlled records, including batch/test records, logs, reports, and quality management documentation
• Aid in preparing materials for internal audits and ensure documentation readiness for regulatory inspections
• Collaborate with senior team members to improve and implement quality management systems and training programs
• Aid in preparing reports and documentation related to deviations, corrective actions, and change controls
• Support Quality Management System (QMS) activities including investigations, complaints, CAPAs, inspections, quality metrics, and continuous improvement initiatives.

Requirements

• Bachelor’s Degree in a related field and/or 3-5 years related experience in a regulated industry
• Minimum of three (3) years of relevant QA experience in a GMP-regulated environment
• Hands-on experience with full Veeva Vault or Veeva Basics implementations, ideally within the Vault Quality Suite (QualityDocs, QMS, Training)
• Veeva Vault Administrator or Vault Quality certification (a plus)
• Strong working knowledge of GxP, 21 CFR Part 11, Annex 11, and core quality system processes
• Experience working with global teams and regulated environments
• Experience in managing enhancements post-implementation and supporting continuous improvement
• Strong written and verbal communications skills
• Attention to detail and ability to manage multiple priorities

Salary

$95,000.00 - $115,000.00 annual salary