Quality System Specialist (Veeva eQMS)

Essentials Duties and Responsibilities
- Lead or support Veeva Basics implementations for QualityDocs, 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.

Education and Experience Requirements
- 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 (QualityDocs, QMS, Training).
- Veeva Vault Administrator or Vault Quality certification (plus).

Knowledge and Skills Requirements
- 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.

Salary
- $95,000.00–$115,000.00 annual salary.