Assoc. Dir. DDIT DEV RA Sol. Del.

Position 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.

What you’ll bring to the role:

• Cutover planning: Develop and maintain the cutover plans for technical and business go-live, confirming all cutover activities are tracked and adhere to the overall project timelines.
• Plan and coordinate all IT delivery activities leading up to the Veeva Project release after configuration lock, from end-to-end informal testing and validation phases until Go-live. This includes planning QA deployments and test cycles in alignment with testing teams and ensuring timely documentation approvals.
• Stakeholder Management: Collaborate with relevant Novartis stakeholders across all project workstreams, project managers, business leaders, IT teams, and external vendors (Novartis Third Party Supplier) so that all cutover activities are identified, coordinated and dependencies are managed.
• Cutover execution and monitoring: Oversee and drive the execution of cutover activities, focusing on adherence to the defined plan, monitoring progress, and making real-time adjustments as needed.
• Risk & issue management: Identify potential risks, develop mitigation strategies, and proactively resolve issues that may impact cutover success and Communication & reporting: Provide regular status updates to leadership, highlighting key milestones, risks, and resolution strategies.
• 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:

• Bachelor’s or master’s degree in computer science, Engineering, Business, or related field.

• 12+ years of relevant experience as a Cutover Manager is required. Prior experience in Cutover Management for large implementation programs—preferably in the Pharma or Life Sciences domain—with regulatory domain understanding is preferred.
• Project management experience for implementation programs on any technical platform is desired (Veeva is an added advantage). |(Preferrable : SAP Cutover/ Oracle or any ERP)|

Commitment to Diversity & Inclusion:

Novartis embraces diversity, equal opportunity, and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards