Systems, Engineer IV - eQMS DD&T Bengaluru, Karnataka Category: Data, Digital and Technology

Job description

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Job Description Job Description / Role Profile Job/Position: Systems, Engineer IV - eQMS DD&T (DD_TYE_D2_SY_T) BU/Organization: GSQ/DD&T Department: Global Functions Location: Bangalore Management Level: D2 Global Reporting Level (CEO=1): TET-4 Line Manager’s Job/Position Title: eQMS DD&T Lead OBJECTIVES/PURPOSE Manage the key relationships between the business stakeholders and DD&T, financial budget and resourcing to deliver on business opportunities and outcomes and, to drive continuous delivery of value using agile scrum life cycle management from product prototyping, development, optimizations and renewals to product terminations. Includes the role Tech Operations and Support. He is responsible for overseeing the daily operations of technical support services, ensuring the smooth functioning of IT infrastructure and end-user support. This role helps maintain operational stability and efficiency, contributing to Takeda's mission by providing reliable technical solutions and support. Drive development of one or multiple product strategies, fitting into long-term roadmaps and drive the product priority-setting of capabilities and features in response to business needs aligned with enterprise architecture, deployment and product and release management. Proactively monitor and maintain product related end-to-end customer/business experiences and influence relevant stakeholders to support and deliver successful product releases. Partner with peers within DD&T and across Global Data and Technology functions to drive continuous improvement of service processes, user experiences and application optimization aligned with business stakeholders. SCOPE Financial: Est. annual revenue range of accountability*: N/A Est. annual budget of responsibility: N/A Leadership/People: No. of direct reports: n/a No. of indirect reports: 5+ Geographic Scope : Global *if applicable ACCOUNTABILITIES Veeva Vault QMS technical leadership for Deviation/CAPA/Change Control/Complaints across global/multi-site GxP environments; Ownership of GxP/CSV validation strategy and execution for SaaS quality platforms (21 CFR Part 11, EU Annex 11, data integrity/ALCOA+, audit/inspection readiness); Oversee and manage product budgets established in consultation with stakeholders by balancing resources, vision development, prototyping and sustain product teams to deliver and maintain the product (e.g. Manage Invoices from service provider | Manage CAPEX – PREPAID OPEX – OPEX Budget within eQMS domain | Manage Global Purchasing process (PLAY requests – SoW negotiations) | SPOT application management regarding planned budget | MRP management per year) Engage and align with business stakeholders and DD&T on current business plans, strategies and future opportunities and developments, providing product recommendations to build a pipeline of meaningful releases. Manage and influence key stakeholders across business and technology, to develop and convey product visions. Ensure and drive the development of a product vision, strategy and roadmap whilst aligning key stakeholders-based capability and features needs. Maintain- and serve as the communicator- of the product vision for eQMS. Use broad knowledge of Data, Digital & Technology, new and established technology developments and consult with key players to enhance products, to define products, to develop prototypes and to develop a roadmap for ongoing and new product developments. Lead and guide the development of products by using persuasion and negotiating skills to reach agreement on approach, development and implementation. Lead and manage the Product Life Cycle(s) for the business, by translating potential pipeline products to agile development project, work closely with development teams to create new business product releases focusing on additional and/or new functionality, product simplification and to increase transparency. End-to-end solution engineering and release ownership (requirements → process/design authority → configuration/build → test/UAT oversight → deployment/hypercare) Drive the product planning fitting in long-term roadmaps and aligned with short-term release plans. Advanced workflow/lifecycle design and optimization (routing, approval matrices, e-signature steps, timers/SLAs, escalations, exception handling) Integration architecture & delivery oversight for interfaces where applicable, API/middleware coordination, data integrity controls) Platform administration and configuration governance (object/field model, forms/templates, controlled vocabularies, security/roles, audit trails, e-signatures, configuration standards) Regulated SDLC/change control leadership (impact assessments, release documentation, controlled deployments, validated-state maintenance, periodic review support) Drive prioritization of the product backlog to keep agile teams unblocked and aligned. Participate and lead gathering of research to identify articulated and non-articulated product needs. Closely monitor product portfolios and business composition, gather relevant data to continuously gain new insight and adjust roadmaps, offering to optimize performance and effectiveness. Manage and take responsibility for sustainability of the end-to-end customer experience of products developed. Estimate approximate workload requirements and timeline predictions for several to many professionals and continuously monitor and prioritize product developments and workflow and capacity to deliver the most significant value to the product users. Communicate issues and successes up and down in the project groups, GDD&T and the Quality business. Oversee the daily operations for technical support services, including applications, analytics, and device management Major incident/problem management leadership for quality-critical services (severity triage, RCA facilitation, CAPA ownership/support, vendor escalation, on-call readiness). Coordinate with relevant teams to resolve issues, follow-up tasks and actions. Review performance and operational metrics to provide recommendations on architecture and automation Assess and manage operational risks, ensuring compliance with policies and procedures Manage IT vendors and service level agreements (SLAs; SoWs), addressing complaints and enhancing code quality Plan and prioritize application maintenance and updates, ensuring minimal disruption to services Provide onboarding and training for application updates to support teams (L1/L2/L3), especially for external service providers. Senior stakeholder management and enablement (QA process owners, site SMEs, IT, vendors), including training strategy, adoption metrics, and continuous improvement roadmap. Strong financial acumen to deal with vendor contract, payments and financial oversight undefined DIMENSIONS AND ASPEC