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GC Only
Job Title:
Business Analyst with Veeva Vault Location: West Point
PA (Hybrid 2 to 3 days onsite a week)
Must Have Experience:
Deep expertise in Veeva Vault QMS, including end-to-end process design, configuration support, and deployment for core QMS processes.
QMS business domain SME with strong knowledge of end-to-end Deviations and CAPA management, and GMP/GCP/GLP Audits & Inspections processes.
Proven experience as Lead Business Analyst on multiple large-scale QMS implementations within the life sciences / regulated lifecycle industry.
Strong capability in process standardization, simplification, and transformation, including defining global/to-be processes and harmonizing
site or functional variations.
Demonstrated ability to lead and facilitate cross-functional business SME groups, driving alignment on requirements, processes, and design
decisions.
Expertise in eliciting, analyzing, and documenting business requirements, user stories, use cases, and acceptance criteria for complex QMS
solutions.
Experience working in Agile delivery models, collaborating closely with product owners, technical teams, and QA/validation to refine backlogs
and ensure high-quality deliverables.
Strong understanding of GxP, regulatory, and validation requirements related to electronic QMS solutions, including impact on requirements,
testing, and documentation.
Excellent communication and stakeholder management skills, able to translate business needs into clear, actionable specifications and facilitate
workshops and decision-making sessions
Job Description:
Strong understanding of GxP, regulatory, and validation requirements related to electronic QMS solutions, including impact on requirements,
testing, and documentation.
Excellent communication and stakeholder management skills, able to translate business needs into clear, actionable specifications and facilitate
workshops and decision-making sessions.
Proficiency with JIRA and related tools for managing requirements, user stories, traceability, and status, as well as preparing clear business-facing
and leadership updates.
Strong technical writing experience for Veeva Vault QMS, including creation and maintenance of process, system, and user documentation.
Subject matter expertise in QMS processes, specifically Deviations and CAPA, with the ability to accurately translate SME input into clear,
structured documentation.
saikr...@meridiansoft.com
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Feb 18, 2026, 3:37:54 PM (3 days ago) Feb 18
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