Senior Product Owner/Business Analyst - Veeva QMS
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. Key Responsibilities:
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 10+ years of experience in Quality Systems, Product Ownership, or Business Analysis in a GxP-regulated life sciences environment.
- Proven experience implementing or supporting Veeva Vault QMS , especially INV, CAPA, Change Control, and Audit Management modules.
- Hands-on knowledge of ETQ Reliance QMS and 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.
- 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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