Quality System Specialist (Veeva eQMS Specialist)
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Job description
We are seeking an experienced Veeva eQMS Specialist with deep expertise in Veeva Basics, ideally someone who has led or played a key role in full implementations across QualityDocs, QMS, Training, and other Vault Quality modules. This role will partner closely with Quality and cross-functional teams to translate business needs into scalable system design, ensuring that our Veeva ecosystem supports compliant, efficient, and future-ready quality operations. The ideal candidate is detail-oriented, organized, and passionate about driving quality excellence in a fast-paced environment., * 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
- Lead or support historical CMC documents migration in 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
- Assist in preparing materials for internal audits and ensuring documentation readiness for regulatory inspections
- Collaborate with senior team members to improve and implement quality management systems and training programs
- Assist 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.
- Perform additional tasks as assigned
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)
Knowledge and Skills Requirements
- 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
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