Risk & Compliance Manager

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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. 

The Role

Our validation specialists are located at three sites in Bangalore, Mexico City and Bratislava. The teams are organized in what we call Towers, ERP, R&D, Infrastructure etc. This role is intended to support the ERP Tower. 

As Risk & Compliance Manager, you will lead validation activities within the ERP Tower, ensuring compliance with regulatory standards and internal quality requirements. This role involves managing a team of 10+ validation specialists and collaborating across IT, QA, and business units to deliver robust, compliant solutions. 

Key Responsibilities

• Lead and manage a team of 10+ validation specialists within the ERP Tower. 

• Oversee validation and qualification of IT systems and infrastructure to ensure compliance with regulatory standards and internal quality requirements. 

• Define validation strategies and objectives aligned with business and compliance goals. 

• Develop and maintain validation plans, protocols, and schedules; communicate expectations clearly to stakeholders. 

• Identify and mitigate risks in validation processes, implementing proactive strategies for successful outcomes. 

• Coordinate cross-functional teams (QA, IT, engineering, business units) for timely execution of deliverables. 

• Monitor progress and performance, providing regular updates and facilitating review meetings. 

• Ensure complete and accurate documentation per GxP and industry standards. 

• Drive adherence to regulatory guidelines (FDA, EMA) and internal SOPs throughout the lifecycle. 

• Promote continuous improvement by evaluating processes and introducing efficiency enhancements. 

• Manage resource planning and prioritization in close collaboration with business stakeholders. 

Additional Responsibilities

• Act as the primary point of contact for ERP validation demands, ensuring timely assessment and execution of validation activities for new implementations, upgrades, and change requests. 

• Plan and manage validation projects end-to-end, including scope definition, timelines, resource allocation, and stakeholder communication. 

• Ensure risk-based validation approach for ERP systems, balancing compliance requirements with operational efficiency. 

• Collaborate with business process owners and IT teams to align validation deliverables with system functionality and business needs. 

• Maintain validation readiness for audits and inspections, ensuring documentation and processes meet regulatory expectations. 

• Drive standardization of validation practices across ERP systems and related infrastructure globally. 

• Support continuous improvement initiatives by introducing automation or digital tools for validation documentation and reporting. 

• Provide training and guidance to team members and stakeholders on ERP validation principles and compliance requirements. 

• Monitor industry trends and regulatory updates to keep validation strategies current and compliant. 

Qualifications

• Min 10  years of experience in a similar role 

• Proven ability to develop and execute validation strategies for SAP 4/Hana implementations and rollouts , including system upgrades and migrations. 

• Experience from leading or coordination cross functional teams (e.g., IT, QA, Business process owners, project managers and vendors) 

• Strong experience in SAP ERP modules (e.g., Finance, Supply Chain, Manufacturing) and their integration points. 

• Hands-on knowledge of SAP GxP compliance requirements, including validation of SAP cloud solutions and related infrastructure. 

• Bachelors or Master's degree in a relevant scientific or engineering discipline (e.g., Computer Science, Engineering, Chemistry, Pharmacy, or related fields). 

• Experience with PMP or Agile or other iterative project management methodologies is a plus 

• Proven experience as an IT Project Manager, with a track record of successfully delivering IT projects on time and within budget. 

• Strong understanding of project management methodologies and best practices. 

• Excellent leadership, communication, and interpersonal skills. 

• Exceptional problem-solving and decision-making abilities. 

• Proficiency in project management tools and software. 

• Ability to work collaboratively in a cross-functional team environment. 

• Strong organizational skills and attention to detail. 

• Excellent people management skills with experience working in global multi-cultural organizations 

• Ability to balance compliance, efficiency and business needs a risk-based approach 

• Good technical understanding of SAP cloud solutions 

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

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