Assoc. Dir. Ddit Dev Ra Sol. Del.

Role Title: Assoc. Dir. DDIT DEV RA Sol. Del.

Location – Hyd-India #LI Hybrid

About the Role

The primary objective of this position is to serve as a consultant and advisor, offering expert guidance to enhance complex global business processes, products, and services. We seek a seasoned professional in GDD Regulatory Affairs who will lead both the strategic and operational implementation of Veeva Vault capabilities in the Regulatory area. This role is responsible for ensuring alignment with organizational objectives, regulatory requirements, and enterprise architecture standards, whilst promoting product innovation and managing the lifecycle.

As Associate Director – Service Delivery, you will be responsible for leading and coordinating all phases of ongoing Veeva implementations, including data management, migration, test planning, execution, cutover, and quality assurance. This role develops and manages detailed project and cutover plans, oversees technical and business go-live activities, ensures data integrity and regulatory compliance, and drives risk mitigation across testing, migration, and release processes. The role collaborates with stakeholders, manages vendor relationships, communicates project status, and ensures successful delivery through effective planning, monitoring, and issue resolution.

Your responsibilities include but are not limited to

• Project Leadership & Planning:
  Lead and coordinate all phases of the program, including test planning, data migration, cutover, and quality assurance. Develop and manage detailed project and cutover plans, ensuring alignment with overall program timelines and objectives.
  Skills: Project management, planning, leadership, organization.
• Testing & Quality Assurance:
  Design and implement comprehensive test strategies, automate test cases (e.g., using TOSCA), and ensure compliance with GxP, CSV, and regulatory standards. Oversee test execution, defect tracking, and periodic regression releases.
  Skills: Software testing, automation tools, regulatory compliance, quality assurance.
• Data Migration & Integrity:
  Lead data migration activities, including data cleansing, transformation, validation, and post-migration quality checks to ensure accuracy and completeness.
  Skills: Data management, migration tools, analytical thinking, attention to detail.
• Data Management:
  Lead data management activities for RA business in terms of data modelling, data analysis, data cleanup and data mapping. Also provide technical support for applications across domains using RA data.
• Ensure designed solutions are aligned with Data and Analytics strategy standards and roadmap.

Skills: Data management, data model

• Cutover Planning & Execution:
  Develop and maintain cutover plans for technical and business go-live, coordinate all IT delivery activities, and oversee execution to ensure a smooth transition to production.
  Skills: Cutover management, scheduling, adaptability, problem-solving.
• Stakeholder & Vendor Management:
  Collaborate with business leaders, IT teams, external vendors, and regulatory stakeholders to gather requirements, manage expectations, and ensure effective communication and coordination across all workstreams.
  Skills: Stakeholder engagement, vendor management, communication, collaboration.
• Risk & Issue Management:
  Proactively identify, mitigate, and resolve risks and issues across testing, migration, and cutover phases, developing and implementing effective mitigation strategies.
  Skills: Risk management, decision-making, critical thinking.
• Reporting & Documentation:
  Track project status, cutover execution, and test results; provide regular updates to leadership, highlighting milestones, risks, and resolution strategies. Maintain comprehensive documentation for all processes, procedures, and results.
  Skills: Reporting, documentation, communication, process orientation.
• Continuous Improvement:
  Evaluate tools, methodologies, and processes for ongoing improvement, leveraging lessons learned to enhance future implementations.
  Skills: Continuous improvement, technical curiosity, openness to feedback.

Desirable Requirements:

• 12+ years of IT experience Overall experience in cutover, testing, and migration is highly preferred.
• Candidates who have demonstrated capabilities across all three areas will be prioritized.
• Specialized expertise is also valued:
  Candidates with very deep knowledge and hands-on experience in any one of the following areas are strongly encouraged to apply:
  • Validation & Testing:
    Experience in designing and executing test strategies, automating test cases (e.g., TOSCA), and ensuring regulatory compliance (GxP, CSV) for Veeva Vault or similar platforms.
  • Data Migration:
    Proven track record in planning and executing large-scale data migrations, including data cleansing, transformation, validation, and post-migration quality checks, preferably within Documentum or Veeva environments.
  • Cutover Activities:
    Expertise in developing and managing cutover plans, coordinating technical and business go-live activities, and executing cutover for Veeva releases or similar regulated platforms.
• Experience in Veeva Vault or life sciences/pharma domain is preferred.
• Implementation experience of Veeva Submission and Submission Archive module is a plus.
• Multi-national global experience in interacting with senior management, collaborating across boundaries and relationship management, and influencing without authority
• Experience in Regulatory Affairs business processes is a plus (e.g. Registration Management, Submission Management, Submission Content management, Submission Publishing & Clinical Publishing, Product Labeling)
• Experience in Managing GxP Projects and Related Fields is a plus

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

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