Risk and Compliance

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 epicenter 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.

About the role:

The Validation Lead is responsible for overseeing computer systems validation programs across the organization within a regulated cGMP environment. This individual collaborates with cross-functional teams to ensure compliance with industry standards and regulatory requirements, implements risk-based validation strategies, and oversees validation and testing activities using modern tools and methodologies. This role supports Takeda's mission by delivering high-quality, compliant solutions while guiding and developing validation team members to achieve departmental goals.

.

How you will contribute:

• Develop, initiate, and oversee risk-based validation strategies and procedures to ensure compliance with regulatory standards and industry best practices for IT systems and processes.  
• Lead validation planning, execution, and reporting across the organization, including risk assessments, validation deliverables, documentation updates, and driving remediation of issues.  
• Establish, monitor, and report Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs) for validation effectiveness and compliance.  
• Collaborate with business and technology leaders to communicate validation risks and ensure a clear understanding of their impact and required actions.  
• Provide leadership in advancing validation frameworks and documentation processes, aligning with business goals and compliance requirements.  
• Guide and mentor validation team members to develop their expertise and ensure the successful delivery of projects in adherence to Takeda’s compliance standards.
• Continuously improve validation processes by adopting innovative tools and methodologies to enhance efficiency and effectiveness while maintaining regulatory compliance.
• Coordinate with cross-functional teams to ensure a seamless approach to validation and compliance initiatives enterprise-wide.

Skills and qualifications:

• Must have experience working in an Agile environment and use of modern quality tools ( e.g. (MF ALM, Veeva, JIRA, Confluence, Qtest, etc)
• Deep expertise, understanding and knowledge of Computer Systems Validation in a regulated GMP environment for process and software.
• Strong work experience in SAP ERP implementation, validation & Qualifications.
• Understanding of business processes, controls frameworks, compliance and regulations for cGMP.
• Minimum 2 S4/HANA (Green and Brown field) projects implementation experience as validation lead/consultant.
• Strong and excellent experience in SAP/ S4HANA Cloud Infrastructure Qualification including SAP-BTP, AWS SAP RISE platform etc.
• Working knowledge of regulations for electronic systems validation and data integrity (eg 21 CFR Part 11, EU Annex 11, FDA/PICS Data Integrity Guidance)
• Waterfalls, Agile Software Development Life Cycle (SDLC) using Jira, Confluence and DevOps Tools Methodologies.
• Ability to work in a virtual environment in a global organization and to effectively prioritize and execute tasks in a high-pressure environment.
• Self-motivated, high work discipline, pragmatic approach while able to enforce mandate, excellent communication & people skills, strong service and support orientation.
• The ability to manage, coach, and monitor validation team members to ensure that the project is managed and delivered per Takeda Compliance.

As an early-career professional, you handle problems of limited scope and complexity, adhering to established policies and procedures. Your decision-making is within a defined scope, using standardized methods to analyze situations and data. You are developing knowledge of basic principles, theories, and concepts, and beginning to apply industry practices and standards. Typically, this role requires some relevant experience, with contributions mostly related to task-specific activities. Your primary contacts are with your immediate team, and you work under moderate direction and close supervision, following specific, detailed instructions.

• Key Responsibilities
• Lead all aspects of the qualification and validation deliverables of SAP ERP systems to ensure they meet industry standards and regulatory requirements.
• Create and implement detailed validation plans for SAP implementations, aligning with project timelines and deliverables.
• Collaborate with ERP projects and product teams, Quality Assurance, and business collaborators to define validation requirements, ensuring comprehensive testing and compliance.
• Manage and lead Computer Systems Validation project within Takeda DD&T and accountable for ensuring computer system validation documentation for process & regulatory compliance including GxP & SOX.
• Responsible to implement risk-based computer system validation methodology with emphasis on risk identification, assessment and mitigation controls.
• Guide DD&T team, system owners and IT technical members on best practices regarding good documentation procedures related to cGMP and other regulatory requirements.
• Participate & Lead in project teams to create, review, and manage documents as part of the delivery of the project, overseeing the execution of validation plans & validation documents.
• Proficient in project assessment, estimation, and full-cycle project management in JIRA, including story creation to closure.
• Experience with Waterfall and Agile software development life cycle (SDLC) approaches.  
• Worked with Veeva QualityDocs and Confluence to generate SDLC validation documents, including validation plans, risk assessments, and summary reports, as well as automated testing tools such as MF ALM and qTest.
• Collaborate with the project PM and validation Managers to implement enterprise-level SAP-ERP test strategies, methodologies, and approaches for both functional and non-functional test automation, it includes GxP and SOX testing.
• Engage in testing activities such as test planning, test creation, test automation, test execution, defect reporting, and test closure for the SAP-ECC, S4 HANA Migration and implementation Projects.
• Automate test cases using MF ALM, qTest or other relevant frameworks.
• Collaborate with multiple deployment teams to organize testing activities according to different project phases.
• Ensure adherence to standardized testing approaches and best practices.
• Understand the challenges associated with SAP testing and automation and collaborate with the Central Test Management team (VCOE) to develop and provide suitable solutions.
• Coaches, trains, develops, motivates, and evaluates Validation team members to enable their capabilities and accomplish the department’s priorities.

Qualifications

• Experience: 8-10 years of experience in pharmaceutical validation of software applications, quality assurance, cGMP manufacturing.
• Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment.
• Education: Bachelor's degree in a relevant field (e.g., Computer Science, Engineering, Life Sciences).
• Strong understanding of Agile methodologies.
• Excellent communication, presentation, and leadership skills.
• Strong problem-solving skills and willingness to roll up one’s sleeves to get the job done.

• Skilled at working effectively with cross-functional teams in a matrix organization.

WHAT TAKEDA CAN OFFER YOU:

• Takeda is certified as a Top Employer, not only in India, but also globally. No investment we make pays greater dividends than taking good care of our people.

• At Takeda, you take the lead on building and shaping your own career.

• Joining the ICC in Bengaluru will give you access to high-end technology, continuous training and a diverse and inclusive network of colleagues who will support your career growth.

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.

#Li-Hybrid