Contract Role: Lead Process Business Analyst with Veeva Vault /Configure & Design Lead (Business Process Lead) at West Point PA (Hybrid 2 to 3 Days Onsite a Week)

Lead Process Business Analyst with Veeva Vault /Configure & Design Lead (Business Process Lead) West Point PA (Hybrid 2 to 3 days onsite a week) Long Term Contract Candidate will have to go onsite for Client round interview after interview with HCL Tech manager Experienced Process Lead with deep business process knowledge and hands‑on Veeva Vault QMS mastery—requirements through rollout. Leads As‑Is/To‑Be design, drives governance and validation, and accelerates adoption with measurable quality KPIs and change management. 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. • Serve as the primary liaison between technical and non‑technical teams, translating complex technical concepts into clear, business‑friendly language to help stakeholders understand impacts, timelines, risks, and requirements. • Define workshop objectives, coordinate scheduling, prepare materials, facilitate the sessions, document key decisions and outcomes, and distribute meeting notes to ensure alignment and follow‑through. • Identify and engage all relevant stakeholders across Business, IT, Quality, IAM, Integration teams, and external vendors. Drive effective communication, alignment, and timely decision-making. Monitor approvals, manage dependencies, assess cross‑functional impacts, and escalate risks or issues as necessary to keep the program on track. • 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. • Experience developing QMS documentation and supporting SDLC activities (requirements, functional specifications, configuration documents, test scripts, release notes, user guides). • Proficiency in business process mapping and modeling (e.g., workflows, swimlanes, SIPOC), and converting process maps into readable, role-based procedures and work instructions. • Skilled in content creation for a regulated environment, including SOPs, Work Instructions, Job Aids, Quick Reference Guides, training materials, and FAQs. • Strong familiarity with GxP, quality, and regulatory requirements to ensure documentation is complete, compliant, and audit-ready.