Risk & Compliance - ERP / SAP Validation and Qualification

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 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 :

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.

Qualifications

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 :

About ICC in Takeda

#Li-Hybrid

Locations

IND - Bengaluru

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time