Systems, Engineer IV - eQMS DD&T

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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 ASPECTS

Technical/Functional (Line) Expertise 

• Understand the language the product teams use to conduct the business of the team and is conversant with all the tools and techniques required to communicate with and send work to a team.
• Ability to operate within — the domains of any core technologies that the product requires to deliver capabilities if required
• Is effective in business language to technical language as needed to bridge the gap between business and technical professionals engaged in the full product value stream
• Understand the business process / supported by the product and is able to communicate with the relevant stakeholders.
• Advanced proficiency in Microsoft Office 365, capable of navigating complex scenarios independently and providing guidance to others
• Fully independent in managing Active Directory, advising others on its use
• Advanced user of Mac OS, optimizes system performance, and provides guidance
• Developing practical experience in prioritization, requires ongoing supervision
• Skilled in managing a wide range of peripheral devices, resolves complex issues independently
• Advanced proficiency in Information Technology Infrastructure Library, advises others on its application
• Capable of managing complex Local Area Network configurations, provides coaching
• Advanced proficiency in deploying and operating Microsoft Windows 10, coaches others
• Fully proficient in issue tracking, improves processes, and advises others
• Advanced proficiency in Wide Area Networks, applies knowledge in complex situations
• Developing verbal communication abilities, needs coaching to convey messages clearly
• Detailed knowlegde aout internal finalyce and planning application : PLAY – DAS application - SPOT – Apptio – etc.

Leadership

• Ability to build support for QMS initiatives and priorities through influence rather than authority
• Collaborate effectively with Product Engineers, Product Designers on an Ecosystem of Products, Platforms, Analytics and Microservices to give Takeda a modern footprint.
• Collaborate with US based legal departments (Lawers), Gloabla Purchasing department and Global Finalace departments.

Decision-making and Autonomy

·       Ability to operate with minimal supervision while maintaining alignment with leadership intent and priorities.

·       Ability to evaluate and recommend the right technology platforms and software products to solve business problems. 

Interaction

·       Internal Stakeholders:  DD&T function, Digital Quality, QMS subject-matter experts globally, allied groups within DD&T and GDT (upstream); Global Quality and local Quality SMEs

·       External Stakeholders:  Service providers (e.g., Cognizant, UAMS, GCI, Accenture), software and service providers in the QMS space (e.g., Veeva, Honeywell Sparta, Process Stream)

Innovation

·       Support identification of emerging technologies and/or data and digital innovations of potential value in Quality Management

Complexity

·       Products:  Multiple QMS tools and applications enterprise-wide

·        Is effective at conveying the product vision and other messages requiring action, in a way that brings people on board with the vision and builds their enthusiasm about fulfilling it

• undefined

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: 

Education / Experience:

Essential:

• Bachelor's degree or equivalent in a scientific discipline, computer science or business administration is preferred.
• 5 years or more of relevant professional experience in research of development business lines, IT service delivery or related area.
• Professional in-depth knowledge of product management in pharmaceutical industry.
• Experience in stakeholder relationship management. Influential in orchestrating key stakeholders and product teams to turn product vision into reality.
• Excellent oral and written communication skills, business acumen, and enterprise knowledge.
• Extensive experience in design or in implementing solutions or products and preferable experienced in quality improvement.
• Understand design thinking and can explain and convince stakeholders.
• Work with virtual/agile teams in different locations, aligning and adapting different work, culture and communication styles.

Preferred:

·       Master's degree.

• Experience in managing people.
• Experience with regulated systems – good level of understanding of system validation.
• Experience in Agile Scrum delivery.
• Is an accomplished practitioner of design thinking, with a proven track record of developing and exploiting deep customer insights.
• Experience with the design and development of pharmaceutical life science products.
• Able to think counterproductive, out of the box and is able to convince stakeholders.
• undefined

ADDITIONAL INFORMATION

Travel required up to 5% (domestic and international)

Date: xx-Apr 2026                                                                  

                                                                     created by: Dr. Jochen Sprengart

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