Assoc. Dir. DDIT DEV RA TD

Role Title: Assoc. Dir. DDIT DEV RA TD

Location: Hyderabad Hyd-India# LI Hybrid

Role Purpose:

The role of Service Delivery Associate Director in Hyderabad focuses on leading the strategic and operational implementation of Veeva Vault in Regulatory Affairs, ensuring alignment with organizational goals and regulatory compliance. This position requires extensive experience in project leadership, data migration, Validation and testing, and cutover activities within regulated environments.

Project leadership and coordination: The role entails leading all phases of Veeva implementations, including test planning, data migration, cutover, and quality assurance, with a focus on detailed project and cutover plan management. Your responsibilities include but are not limited to

• Testing and quality assurance expertise: Responsibilities include designing and executing test strategies, automating tests using tools like TOSCA, and ensuring compliance with GxP, CSV, and regulatory standards.
• Data management and migration: The position involves overseeing data cleansing, transformation, validation, and post-migration quality checks, along with data modeling and technical support for Regulatory Affairs applications.
• Stakeholder engagement and risk management: The Associate Director collaborates with business leaders, IT teams, and vendors, manages risks and issues proactively, and maintains thorough reporting and documentation to ensure smooth project delivery.
• Testing, Quality and Compliance: Managing multiple releases including Planning and Coordination, Excellent knowledge of Automated Testing including tools. Will be responsible to work closely with PQMs and PM to shape up the key testing deliverables from each Project phase perspective. Review the release schedule, including timelines and deliverables for each release working closely with stakeholders.
• During implementation phase with review the deliverables of Testing team. Coordinate testing activities across multiple releases, ensuring consistent test coverage and timely delivery. Synchronize test cycles with release cycles and manage dependencies. Experience in automating test cases (e.g., TOSCA), and ensuring regulatory compliance (GxP, CSV) for Veeva Vault or similar platforms.
• Test Strategy and Management: Define a comprehensive test strategy for handling multiple releases, including regression testing and impact analysis. Establish clear criteria for release readiness and quality gates for each phase. Ensure test objectives align with overall project scope and goals.
• Change and Configuration Management: Manage configuration and change control processes to track and document changes across releases. Ensure consistency and integrity of test environments to reflect production-like scenarios. Oversee version control for test cases, scripts, and data as per release requirements.
• Resource Allocation: Optimize resource allocation to handle overlapping test cycles and peak workloads. Plan for adequate staffing levels, skills, and availability to meet testing demands of multiple releases. Ensure effective resource utilization across releases.

What you’ll bring to the role:

• Risk Management :Identify and analyze risks specific to multiple releases, including cumulative effects and interactions. Develop and implement risk mitigation plans tailored to multi-release projects. Conduct regular risk assessments and update stakeholders on potential impacts.
• Test Execution and Defect Tracking :Plan and coordinate test execution activities for each release, ensuring minimal disruption to ongoing tests. Maintain a centralized defect tracking system to monitor and resolve issues across all releases. Ensure timely feedback and resolution of defects to meet release schedules.
• Releases and Regression Testing: Implement robust regression testing practices to ensure new releases don’t introduce unforeseen issues. Maintain regression test suites and ensure they are up-to-date and comprehensive. Ensure coordination of regression tests across all releases to validate system stability and functionality.
• Continuous Integration and Automation: Leverage continuous integration and automation tools to streamline testing processes for frequent releases. Ensure automated tests cover critical paths and high-risk areas consistently across multiple releases. Monitor and enhance automation coverage to support release cycles effectively.
• Stakeholder Communication: Facilitate regular communication with all stakeholders, including developers, product managers, and clients regarding release progress and issues. Provide detailed test status reports, highlighting readiness, risks, and issues for each release. Ensure transparency and alignment between teams to maintain project momentum.
• Continuous Improvement and Lessons Learned :Analyze testing outcomes from previous releases to identify improvement areas. Implement lessons learned and best practices to enhance subsequent release quality and efficiency. Encourage a culture of continuous learning and improvement within the testing team. These key points cover essential responsibilities and strategies for a Test Management

Desirable Requirements:

• Education & Qualifications bachelor’s degree in computer science, Computer Engineering or related technical discipline or equivalent experience demonstrated

• 12+ years of IT experience with hands on 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:
• 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. and 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) and experience in Managing GxP Projects and Related Fields is a plus.

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