
Document Management Specialist
4 weeks ago
Role Overview:
We are seeking an experienced Subject Matter Expert (SME) – DMS (Veeva Vault) who will be responsible for leading and supporting the deployment and optimization of the Veeva Vault Document Management System (DMS) across global Life Sciences operations. This role requires deep expertise in document lifecycle management, regulatory compliance, and the ability to translate user needs into streamlined,compliant workflows.
Key Responsibilities:
- Serve as the primary SME for the Veeva Vault DMS platform, driving successful deployment, configuration, and optimization.
- Possess strong knowledge of the documentation lifecycle, including creation, review, approval, release, versioning, archival, and retrieval processes.
- Assess existing document management processes, identify gaps, inefficiencies, and non-compliance risks, and recommend improvements aligned with industry best practices and regulatory standards (e.g., GxP, 21 CFR Part 11, Annex 11).
- Collaborate with cross-functional stakeholders, including Quality, Regulatory, IT, and Business teams to gather user requirements, design intuitive workflows, and configure DMS functionality accordingly.
- Work closely with implementation partners, system integrators, or internal technical teams to design user-friendly workflows that are compliant with applicable regulatory guidelines.
- Lead or support UAT, training, and change management activities during and post-Veeva Vault DMS implementation.
- Act as a point of contact for troubleshooting, support, enhancements, and future scalability of the DMS system.
- Ensure that all documentation processes support data integrity, audit readiness, and regulatory compliance
Required Skills & Qualifications:
- 8+ years of experience in Document Management Systems, with at least 3–5 years specifically on Veeva Vault DMS in a lead or SME capacity.
- Strong understanding of Life Sciences documentation processes across R&D, Quality, Regulatory, and Compliance domains.
- Proven experience in end-to-end Veeva DMS implementation or transformation projects, including configuration, testing, rollout, and post-go-live support.
- Demonstrated experience in process design, gap analysis, stakeholder engagement, and workflow optimization.
- Excellent knowledge of compliance requirements and documentation standards relevant to the pharmaceutical or biotech industry.
- Strong communication, facilitation, and problem-solving skills.
Preferred Qualifications:
- Experience working in regulated environments (GxP).
- Veeva Vault certification is a plus.
- Familiarity with other Veeva modules like QMS or LMS is an added advantage.
- Experience working with global stakeholders in a matrixed environment.
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