• US Citizen

• Green Card

• EAD (OPT/CPT/GC/H4)

• H1B Work Permit

• Corp-Corp

• W2-Permanent

• W2-Contract

• Contract to Hire

• Consulting/Contract

• UG :- - Not Required

• PG :- - Not Required

• No of position :- ( 1 )

• Post :- 9th Apr 2025

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.

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.

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.

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.

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.

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.

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.