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Job details:
Role Description
Role Description
Job Title:Lead II Veeva Vault - Life Sciences (QA & RA)
(Mandatory Certification: Veeva Platform Administrator Certification and/or Veeva RIM and Quality Training certified from Veeva Education Services)
Job Summary
We are seeking highly skilled and experienced
Life Sciences (LS)Quality Assurance and Regulatory Affairs professionals to join our LS Practice team. The ideal candidate should have hands-on experience on
Veeva Vault Solutions across
Regulatory,
Quality Modules, CSV/Validation, and regulated documentation, strong analytical skills, and the ability to translate complex technical and compliance requirements into clear, client-ready solutions and a good understanding of global regulatory agencies process.
Key Responsibilities
- The role involves hands-on configuration and customization of Veeva Vault Regulatory & Quality applications to meet business and regulatory requirements, active participation in quarterly Vault release cycles (including impact assessments, configuration updates, validation, and post-release support), and ongoing system support and enhancement.
- Lead end-to-end implementation of Veeva Vault Quality modules (QMS, Training, eTMF, QualityDocs) and Veeva Vault Regulatory modules(Registration, Submissions, Submission Publishing, Submission Archive).
- Provide end-user support for incidents and problem tickets, including root cause analysis and remediation.
- Configure Vault Regulatory and Quality components aligned to project requirements (lifecycles, document types, metadata, security) and contribute to environment strategy (dev/test/prod).
- Collaborate with stakeholders to document requirements, implement changes, and validate solutions in compliance with GxP standards (Deviations, CAPA, Change Control, Audits).
- Develop and execute migration strategies, test plans, and reconciliation processes to ensure data accuracy and completeness.
- Utilizing the assigned Veeva system(s) to manage and maintain regulatory information, track submissions, health authority correspondence, and approvals across regions and functions. Support data migration, configuration, validation, and User Acceptance Testing (UAT).
- Design, develop, and maintain automation scripts for Veeva Vault applications.
- Automate validation of Vault configurations, workflows, objects, and lifecycle rules. Build automated regression suites aligned with GxP compliance.
Mandatory Skills: (Must Have Skills)
- Active Veeva Vault Administrator Certificate (Regulatory & Quality) and practical experience in configuration, administration, migrations & problem solving, with strong understanding of Vault configuration concepts: lifecycles, security model, document types, metadata, and workflows.
- Familiar with FDA, EMA regulations and GxP, 21 CFR Part 11 Compliance requirements and ensuring adherence to regulatory standards.
- Proven ability to troubleshoot incidents, analyze problems, and deliver timely fixes in production and non-production environments.
- Experience in Life Sciences processes (Quality events, CAPA, Deviations, Audits).
- Agile, Lean and ITIL process knowledge.
- Experience leading global or enterprise Vault implementations.
- Experience in Data migration or integration consulting including data mapping, transformation, cleansing, and validation using Veeva Migration tools (e.g., Vault Loader, Veeva API, ETL tools)
- Ability to analyse, transform, and validate complex datasets.
- Strong analytical and problem-solving skills, effective communication and stakeholder management abilities and detail-oriented with a focus on quality and compliance.
Optional Skills: (Good to Have Skills)
- Familiarity with Life Sciences (Pharmaceutical/ Biologics/ Medical Devices/ Diagnostics) commercial processes.
- Understanding compliance and regulatory requirements in Pharma.
- Exposure to multiple Vault Modules (QualityDocs, QMS, RIM, Promomats, Medcomms, Veeva-Clinical, DMS) is plus.
- Experience with Content Management Systems such as Documentum, Trackwise, SharePoint.
- Knowledge of Vault APIs, Postman, and integration tools.
- Familiarity with Vault Java SDK, VQL for advanced customization.
Qualification And Experience
- Masters/ Bachelors degree in Life Sciences/ Engineering.
- 10+ years of experience & certification with Veeva Vault, including enterprise implementation and operation of Veeva solutions in a regulated environment.
- Experience in configuring and resolving issues in multiple Veeva Vaults is required.
- Ability to influence stakeholders and work closely with them to determine acceptable solutions.
Skills
regulatory affairs,capa,fda regulations,quality management system,veeva vault administration,
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