Senior Product Owner/Business Analyst - Veeva QMS

We are seeking an experienced and strategicSenior Product Owner / Business Analystwith deep technical expertise inVeeva Quality Management Systems (QMS)to lead the transition fromETQ ReliancetoVeeva Vault QMS. This role will be instrumental in defining the product vision, collaborating with cross-functional teams, and driving successful delivery of business-critical functionality, particularly acrossInvestigations (INV),Corrective and Preventive Actions (CAPA),Change Control, andAudit Readinessmodules.

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The ideal candidate has 10+ years of experience in quality systems and regulated system implementations, strong stakeholder engagement skills, and a deep understanding of GxP compliance, data integrity, and Agile delivery. Experience with both Veeva and ETQ QMS platforms is highly desirable.

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Key Responsibilities:

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Product Ownership & Strategy

   • Define and maintain a clear product vision and roadmap for Veeva QMS that aligns with business objectives and regulatory requirements

   • Lead strategic planning for the transition from ETQ Reliance to Veeva Vault QMS, including system sunset, data migration, and business process alignment

   • Serve as a trusted advisor to business leadership on system capabilities, scalability, and improvement opportunities

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Functional Ownership of QMS Modules

   • Serve as Product Owner for the following QMS modules:

   • Investigations (INV)

   • Corrective and Preventive Actions (CAPA)

   • Change Control

   • Audit Management / Readiness

   • Work with Global Process Owners and SMEs to align module functionality with business process expectations and compliance standards

   • Ensure consistent and effective cross-module integration and workflow orchestration within the Veeva Vault platform

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Requirements Management

   • Elicit, document, and validate business, functional, and technical requirements

   • Translate business processes into detailed user stories and acceptance criteria, ensuring traceability and testability

   • Define and maintain the product backlog, prioritizing based on business value, dependencies, and readiness

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Agile Delivery & Development Oversight

   • Participate actively in Agile ceremonies, including sprint planning, backlog grooming, stand-ups, demos, and retrospectives

   • Guide and support development and testing teams throughout the sprint lifecycle, ensuring alignment with business expectations

   • Monitor and communicate sprint progress, risks, and mitigation strategies

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System Validation & Documentation

   • Author or contribute to validation deliverables such as URS, configuration specifications, test scripts, and traceability matrices

   • Ensure that all development aligns with 21 CFR Part 11, Annex 11, and internal GxP and data integrity standards

   • Support audit readiness and inspections by maintaining robust documentation and traceability

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Stakeholder Engagement

   • Collaborate closely with GPOs, SMEs, IT, Quality, and Compliance stakeholders

   • Facilitate workshops and working sessions to gather input, drive consensus, and ensure adoption

   • Serve as a liaison between business and technical teams to translate needs into system functionality

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Data Strategy & Migration

   • Contribute to the development of a forward-looking data strategy supporting both migration from ETQ and future reporting/analytics needs

   • Collaborate with data teams to define mapping, cleansing, and migration rules

   • Support execution and validation of data migration from ETQ to Veeva

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Qualifications:

   • 10+ years of experience in Quality Systems, Product Ownership, or Business Analysis in a GxP-regulated life sciences environment

   • Proven experience implementing or supportingVeeva Vault QMS, especially INV, CAPA, Change Control, and Audit Management modules

   • Hands-on knowledge ofETQ Reliance QMSand experience supporting QMS platform transitions is strongly preferred

   • Strong understanding of quality processes and regulatory expectations (GAMP 5, 21 CFR Part 11, Annex 11, etc.)

   • Experience with Agile/Scrum delivery methodologies and tools (e.g., JIRA, Confluence)

   • Excellent communication, facilitation, and stakeholder management skills

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Preferred Qualifications:

   • Veeva Vault Administrator training or certifications

   • Experience with global rollouts of QMS platforms

   • Familiarity with data migration and data integrity best practices

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