Business Integration Lead eQMS

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Job Description

The Future Begins Here

At Takeda, we are leading digital evolution and global transformation. By building innovative solutions and future-ready capabilities, we are meeting the need of patients, our people, and the planet.

Bengaluru, the city, which is India’s epicentre of Innovation, has been selected to be home to Takeda’s recently launched Innovation Capability Center. We invite you to join our digital transformation journey. In this role, you will have the opportunity to boost your skills and become the heart of an innovative engine that is contributing to global impact and improvement.

At Takeda’s ICC we Unite in Diversity

Takeda is committed to creating an inclusive and collaborative workplace, where individuals are recognized for their backgrounds and abilities they bring to our company. We are continuously improving our collaborators journey in Takeda, and we welcome applications from all qualified candidates. Here, you will feel welcomed, respected, and valued as an important contributor to our diverse team.

OBJECTIVES/PURPOSE

• Leads analysis, defines and establishes design of all technical aspects or provides technical expertise for digital and technology solutions on intermediate and large complexity applications or systems, and/or projects within area of expertise.
• Maintains and uses knowledge of solutions and technology landscape to explore and identify possible solutions related to defined technical problems and finds opportunities to improve business solutions support.
• Maintains and partly creates elements of complex solutions.
• Delivers system solutions and supports for Quality Management System (QMS) processes across the TrackWise and / or Veeva platform.
• Serves as the Senior Technical SME and Administrator for eQMS applications and other technologies as assigned.
• Supports design, implementation, governance and run activities in collaboration with cross-functional business and Data, Digital & Technology (DD&T) areas.

How you will contribute:

The role encompasses managing the development lifecycle of workflows across eQMS platforms like Veeva and TrackWise. Responsibilities include:

• Workflow Development: Independently configure and develop business workflows based on user requirements.
• Reporting: Create reports and dashboards utilizing eQMS reporting tools and QlikSense.
• Technical Problem Solving: Address and escalate complex technical issues that arise during operations.
• Support & Troubleshooting: Provide system support and manage resolutions effectively.
• Documentation: Develop technical specifications and execute test cases according to SDLC, Agile, and ITIL standards.
• Agile Methodology: Apply advanced Agile practices in project settings while mentoring others.
• Process Improvement: Analyze and optimize workflows while establishing guidelines for improvement in complex scenarios.
• Project Management: Guide complex projects using AGILE/Waterfall methodologies while mentoring team members.
• Vendor Coordination: Manage deliverables with external vendors and maintain technical relationships.
• Technical Roadmaps: Develop and maintain roadmaps aligning business needs with IT solutions.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• As an experienced professional, you specialize in solving various complex problems, sometimes referring to established precedents and policies. Your work involves analyzing diverse data and selecting appropriate methods for solutions, while networking with senior professionals in your field. You possess a complete understanding of principles, concepts, and industry practices, exerting some influence on organizational objectives. You often work independently under general direction, occasionally leading small project teams, and may represent the organization in contractual or project matters, interacting with senior internal and external personnel. You might also participate in training junior staff.
• Solid understanding of cloud-based and cloud-hosting application architectures including the management of system configurations, interfaces, and software releases.
• Basic understanding of GxP computer systems validation, Software Development Lifecycle, and IT Service Management.
• Knowledge of emerging technology trends and digital capabilities relevant to environment, health, safety, and sustainability.

Leadership

• Ability to build support for QMS initiatives and priorities through influence rather than authority

Decision-making and Autonomy

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

Interaction

• Internal Stakeholders:  DD&T function, Digital Quality, QMS subject-matter experts globally (GQ – Quality), allied groups within DD&T (ICCs) and GDD&T (upstream)
• External Stakeholders:  Service providers (e.g., Cognizant UAMS, AWS), software and service providers in the QMS space (e.g., Honeywell Sparta, VEEVA)

Innovation

• Support identification of emerging technologies and/or data and digital innovations of potential value in QMS capabilities

Complexity

• Products:   Multiple QMS tools and applications enterprise-wide and AI driven Digital Assistants and EDB related data dashboard applications

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Education / Experience:

Essential:

• Bachelor Degree or equivalent in Business, Computer Science, Information Systems, or equivalent education.
• 5+ years or more of relevant experience.
• Expertise and experience in TrackWise administration, configuration (TeamAccess, WebAdmin, PR Import, Selection Import, Admin Queries, Workflows), Java web services and Crystal Reports development.
• Technical experience in relational database management software including Oracle and MS SQL, specifically SQL querying and navigating complex data structures.
• Knowledge of computer systems validation practices.
• Extensive experience implementing solutions and using different Quality Systems in the pharmaceutical or Life Science Industry
• Strong analytical and problem solving skills.
• Ability to write and speak in the English language.
• Excellent oral and written communications skills, business acumen with problem solving and analytical skills.
• Up-to-date expertise in the solution area assigned and continuously enhances own skills.  
• Is considered a subject matter expert in the technical area of expertise.

Preferred:

• Master Degree.
• TrackWise implementation experience in Pharma/Life Sciences/Medical Device companies.
• Experience and knowledge of Agile methodology for continuous implementation.
• Expertise and experience in QlikView and/or QlikSense reporting development.
• Experience with other tracking software systems or quality management system applications is preferred.
• Quality business process knowledge in Change Controls, Complaints, Deviations, CAPAs, Supplier Management, and Audits.
• Understanding of IT service management processes and associated tools (e.g. ServiceNow).
• Experience of managing third party vendors and off-shore technical teams.
• Knowledge of Javascript and CSS scripting language preferred.

ADDITIONAL INFORMATION

Travel required up to 5% (domestic and international)

Benefits:

It is our priority to provide competitive compensation and a benefit package that bridges your personal life with your professional career. Amongst our benefits are:

• Competitive Salary + Performance Annual Bonus
• Flexible work environment, including hybrid working
• Comprehensive Healthcare Insurance Plans for self, spouse, and children
• Group Term Life Insurance and Group Accident Insurance programs
• Employee Assistance Program
• Broad Variety of learning platforms
• Diversity, Equity, and Inclusion Programs
• Reimbursements – Home Internet & Mobile Phone
• Employee Referral Program
• Leaves – Paternity Leave (4 Weeks) , Maternity Leave (up to 26 weeks), Bereavement Leave (5 calendar days)

About ICC in Takeda

• Takeda is leading a digital revolution. We’re not just transforming our company; we’re improving the lives of millions of patients who rely on our medicines every day.
• As an organization, we are committed to our cloud-driven business transformation and believe the ICCs are the catalysts of change for our global organization.

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time