Quality System Specialist; Veeva eQMS

Essentials Duties and Responsibilities

• Lead or support Veeva Basics implementations for Quality Docs, Quality Events, Supplier Quality, supporting SOPs, and training.
• Configure/optimize workflows, document types, metadata, training assignments, quality processes, and user roles.
• Conduct process mapping for current/future eQMS processes (document management, change control, deviations, CAPA, complaints, training).
• Facilitate cross-functional workshops and deliver user training.
• Lead/support migration of historical CMC documents into Veeva.
• Identify opportunities for process improvements and automation.
• Maintain Veeva release updates (impact assessments and SOP revisions).
• Provide ongoing support, troubleshoot issues, and manage enhancement requests.
• Serve as Veeva Basics SME for Quality.
• Maintain controlled records (batch/test records, logs, reports, and quality documentation).
• Support internal audit readiness and regulatory inspection documentation.
• Support QMS activities: investigations, complaints, CAPAs, inspections, quality metrics, continuous improvement.

• Bachelor’s degree in a related field and/or 3–5 years in a regulated industry.
• Minimum 3 years QA experience in a GMP-regulated environment.
• Hands-on Veeva Vault or Veeva Basics implementations (Quality Docs, QMS, Training).
• Veeva Vault Administrator or Vault Quality certification (plus).

• GxP, 21 CFR Part 11, Annex 11, and core quality system process knowledge.
• Experience with global teams and regulated environments.
• Experience managing enhancements post-implementation/continuous improvement.
• Strong written/verbal communication; attention to detail; ability to manage multiple priorities.

• $95,000.00–$ annual salary.