What are the responsibilities and job description for the Senior Product Owner/Business Analyst - Veeva QMS position at ILB Consulting Services?
We are seeking an experienced and strategic Senior Product Owner / Business Analyst with deep technical expertise in Veeva Quality Management Systems (QMS) to lead the transition from ETQ Reliance to Veeva 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 across Investigations (INV), Corrective and Preventive Actions (CAPA), Change Control, and Audit Readiness modules.
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.
Qualifications:
- 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.
Preferred Qualifications:
- Veeva Vault Administrator training or certifications
- Experience with global rollouts of QMS platforms
- Familiarity with data migration and data integrity best practices
